[Federal Register Volume 75, Number 152 (Monday, August 9, 2010)]
[Notices]
[Pages 48180-48233]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19342]
[[Page 48179]]
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Part III
Department of Health and Human Services
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Food and Drug Administration
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Comprehensive List of Guidance Documents at the Food and Drug
Administration; Notice
Federal Register / Vol. 75, No. 152 / Monday, August 9, 2010 /
Notices
[[Page 48180]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1998-N-0050] (formerly Docket No. 1998N-0046)
Comprehensive List of Guidance Documents at the Food and Drug
Administration
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is publishing a
comprehensive list of all guidance documents currently in use at the
agency. This list is being published under FDA's Good Guidance
Practices (GGPs). It is intended to inform the public of the existence
and availability of all of our current guidance documents. It also
provides information on guidance documents that have been added or
withdrawn in the past 5 years.
DATES: We welcome general comments on this list and on agency guidance
documents at any time.
ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
For information on a specific guidance or to obtain a paper copy,
please refer to each Center's section of this document.
SUPPLEMENTARY INFORMATION:
I. Background
FDA's GGPs were published in the Federal Register of September 19,
2000 (65 FR 56468), and became effective October 19, 2000. GGPs (21 CFR
10.115) are intended to ensure involvement of the public in the
development of guidance documents, and to enhance understanding of the
availability, nature, and legal effect of such guidance.
FDA has adopted a new format for the publication of its
comprehensive guidance list. This new format is intended to increase
the timeliness of the comprehensive list. For information on a specific
guidance or to obtain a paper copy, please refer to each Center's
section of this document. The lists of guidance documents are either a
printout of FDA's Web site as of April 2010 or a list compiled by the
issuing office. You should note that some guidance documents pertain to
more than one product area (e.g., drugs and biologics), and are,
therefore, listed under both Centers involved or pertain to more than
one subject matter (e.g., ``Food Defense and Emergency Response'' and
``Imports''), and are, therefore, listed under more than one category
within a Center. So there may be some duplication in the guidance
lists. You are encouraged to use FDA's Web site as the most up-to-date
source for all current guidance documents in use by the agency, as the
Web site is updated on a daily basis.
In accordance with the agency's general policy on guidances, you
may comment on this list and on any FDA guidance document at any time.
We have organized the guidance documents by the issuing Center or
Office within FDA. The dates in the list refer to the date we issued
the guidances or, where applicable, the last date we revised a
document. Because each issuing Center or Office maintains its own
database, there are slight variations in the way in which they provide
the information.
II. Center for Biologics Evaluation and Research (CBER)
For information a specific guidance document or to obtain a paper
copy, contact:
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448, 1-800-835-4709 or 301-827-
1800, e-mail: [email protected], http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
The following is a list of CBER guidance documents that have been
withdrawn:
------------------------------------------------------------------------
Date of Date of
Title of Document Issuance Withdrawal
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Guidance for Industry: Gamma Irradiation 3/15/2000 4/10/2006
of Blood and Blood Components: A Pilot
Program for Licensing
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Draft Guidance for Industry: CBER Pilot 7/11/2001 4/11/2006
Licensing Program for Immunization of
Source Plasma Donors Using Immunogen Red
Blood Cells Obtained from an Outside
Supplier
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Draft Guidance for Industry: Submitting 8/23/2001 August 9,
Type V Drug Master Files to the Center 2010.
for Biologics Evaluation and Research
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The following list of current CBER guidance documents was obtained
from FDA's Web site on April 20, 2010:
Administrative
Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments,
and Proposed REMS Modifications (PDF - 316KB)
9/2009
Formal Meetings Between the FDA and Sponsors or Applicants (PDF - 89KB)
5/2009
Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific
Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices
1/2009
Guidance for Industry, FDA Staff, and FDA-Accredited Third Parties - Manufacturer's Notification of
the Intent to Use an Accredited Person under the Accredited Persons Inspection Program Authorized by Section
228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)
9/15/2005
[[Page 48181]]
Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The
Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation
Criteria
10/4/2004
Guidance for Industry and FDA Staff - User Fees and Refunds for Premarket Notification Submissions
(510(k)s)
5/28/2004
FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock
and Performance Assessment
5/21/2004
Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications
11/24/2003
Premarket Approval Application Modular Review
11/3/2003
Adverse Events and Product Deviation Guidances
Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs--Improving
Human Subject Protection (PDF - 61KB)
1/2009
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an
Influenza Pandemic (PDF - 246KB)
12/2008
Providing Regulatory Submissions in Electronic Format--Postmarketing Individual Case Safety Reports
(PDF - 107KB)
6/2008
Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of
Biological Products Other than Blood and Blood Components
10/2006
Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products--Content
and Format (PDF - 52KB)
1/2006
Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines (PDF -
375KB)
3/2001
Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products:
Clarification of What to Report (PDF - 95KB)
8/1997
Allergenic Guidance Documents
Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts
11/20/2008
Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A
Revised Protocol
11/20/2000
Guidance for Industry On the Content and Format of Chemistry, Manufacturing and Controls Information
and Establishment Description Information for an Allergenic Extract or Allergen Patch Test
4/23/1999
Application Submissions
Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug
Products Terminally Sterilized by Moist Heat Processes (PDF - 73KB)
2/2010
SPL Standard for Content of Labeling Technical Qs & As (PDF - 58KB)
10/2009
Investigator Responsibilities--Protecting the Rights, Safety, and Welfare of Study Subjects (PDF -
163KB)
10/2009
Providing Regulatory Submissions in Electronic Format--(PDF - 123KB)
5/2009
Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) -
The PMA Supplement Decision-Making Process (PDF Version) (PDF - 180KB)
12/2008
Contents of a Complete Submission for the Evaluation of Proprietary Names (PDF - 306KB)
11/2008
Tropical Disease Priority Review Vouchers (PDF - 112KB)
10/2008
Integrated Summary of Effectiveness (PDF - 95KB)
8/2008
Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA
Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers (PDF Version) (PDF - 121KB)
8/2008
Providing Regulatory Submissions in Electronic Format--Postmarketing Individual Case Safety Reports
(PDF - 107KB)
6/2008
Providing Regulatory Submissions in Electronic Format -Human Pharmaceutical Product Applications and
Related Submissions Using the eCTD Specifications (PDF - 133KB)
6/2008
Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications
(PMAs): Effect on FDA Review Clock and Goals (PDF Version) (PDF - 155KB)
6/2008
Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s,
Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements (PDF Version) (PDF - 103KB)
2/2008
Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices (PDF
Version) (PDF - 127KB)
2/2008
Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and
Research (CBER) in Electronic Format - Lot Release Protocols (PDF - 76KB)
11/2007
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In Vitro Diagnostic (IVD) Device Studies--Frequently Asked Questions (PDF - 268KB)
10/2007
Pharmacogenomic Data Submissions--Companion Guidance (PDF - 211KB)
8/2007
Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single
Submission (PDF Version) (PDF - 145KB)
6/2007
Providing Regulatory Submissions in Electronic Format--Receipt Date (PDF - 59KB)
6/2007
Draft Guidance for Industry and FDA Staff - Annual Reports for Approved Premarket Approval
Applications (PMA) (PDF Version) (PDF - 127KB)
10/2006
Real-Time Premarket Approval Application (PMA) Supplements - Guidance for Industry and FDA Staff (PDF
Version) (PDF - 82KB)
4/2006
Reports on the Status of Postmarketing Study Commitments--Implementation of Section 130 of the Food
and Drug Administration Modernization Act of 1997 (PDF - 456KB)
2/2006
Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (PDF
- 295KB)
2/2006
Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (PDF -
110KB)
2/2006
Fast Track Drug Development Programs - Designation, Development, and Application Review (PDF - 83KB)
2/2006
How to Comply with the Pediatric Research Equity Act (PDF - 116KB)
9/2005
Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (PDF - 230KB)
5/2005
Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software
Contained in Medical Devices (PDF version) (PDF - 342KB)
5/2005
Providing Regulatory Submissions in Electronic Format--Content of Labeling (PDF - 28KB)
4/2005
Good Review Management Principles and Practices for PDUFA Products (PDF - 683KB)
4/2005
Pharmacogenomic Data Submissions (PDF - 96KB)
3/2005
Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (PDF
- 211KB)
12/2004
Guidance for Industry and FDA Staff: Resolution of Disputes Concerning Payment or Refund of Medical
Device User Fees Under MDUFMA (PDF Version) (PDF - 97KB)
11/2004
Guidance for Industry, FDA Staff, and Third Parties - Inspection by Accredited Persons Under The
Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation
Criteria (PDF Version) (PDF - 175KB)
10/2004
Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Notification Submissions
(510(k)s) (PDF Version) (PDF - 109KB)
5/2004
Guidance for Industry and FDA Staff - FDA and Industry Actions on Premarket Notification (510(k))
Submissions: Effect on FDA Review Clock and Performance Assessment (PDF Version) (PDF - 515KB)
5/2004
Guidance for Industry and FDA: User Fees and Refunds for Premarket Approval Applications (PDF
Version) (PDF - 87KB)
11/2003
Guidance for Industry and FDA Staff: Premarket Approval Application Modular Review (PDF Version) (PDF
- 159KB)
11/2003
Providing Regulatory Submissions in Electronic Format - General Considerations (PDF - 288KB)
10/2003
Part 11, Electronic Records; Electronic Signatures--Scope and Application (PDF - 215KB)
8/2003
Guidance for Industry and FDA Staff: Premarket Approval Application Filing Review (PDF Version) (PDF
529KB)
5/2003
Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement
Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products
2/2003
Comparability Protocols--Chemistry, Manufacturing, and Controls Information (PDF - 240KB)
2/2003
Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA
Staff - PDF (PDF - 548KB)
2/2003
Special Protocol Assessment (PDF - 36KB)
5/2002
Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format--Investigational
New Drug Applications (INDs) (PDF) (PDF - 80KB)
3/2002
Cancer Drug and Biological Products - Clinical Data in Marketing Applications (PDF - 39KB)
10/2001
Draft Guidance for Industry - Submitting Type V Drug Master Files to the Center for Biologics
Evaluation and Research
9/2001
[[Page 48183]]
Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (PDF -
50KB)
8/2001
Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (PDF -
32KB)
4/2001
Acceptance of Foreign Clinical Studies (PDF - 12KB)
3/2001
Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) (PDF - 56KB)
11/2000
Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (PDF - 26KB)
10/2000
Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic,
Biotechnology-Derived Products (PDF - 14KB)
10/2000
Formal Meetings With Sponsors and Applicants for PDUFA Products (PDF - 30KB)
2/2000
Formal Dispute Resolution: Appeals Above the Division Level (PDF - 30KB)
2/2000
Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act
(PDF - 57KB)
9/1999
Submission of Abbreviated Reports and Synopses in Support of Marketing Applications (PDF - 43KB)
8/1999
Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in
Electronic Format - Biologics Marketing Applications (PDF - 582KB)
11/1999
Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory
Committees (PDF - 62KB)
10/1998
Submitting Debarment Certification Statements (PDF - 144KB)
9/1998
Standards for Prompt Review of Efficacy Supplements (PDF - 76KB)
5/1998
Classifying Resubmissions in Response to Action Letters (PDF - 76KB)
4/1998
Pediatric Use Supplements--Content and Format (PDF - 24KB)
5/1996
Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs (PDF
41KB)
11/1995
Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs,
Including Well-Characterized, Therapeutic, Biotechnology-derived Products (PDF - 42KB)
11/1995
FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and
Manufacture of Biological Products; Availability (PDF - 34KB)
7/1995
Submission Documentation for Sterilization Process Validation in Applications for Human and
Veterinary Drug Products (PDF - 57KB)
11/1994
Preparation of Investigational New Drug Products (Human and Animal) (PDF - 795KB)
3/1991
Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance
with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration
Amendments Act of 2007
Blood Guidance Documents
Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood
Components, October 2009 (PDF - 858KB)
10/2009, Updated: 12/2009
Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood
Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus (PDF - 80KB)
11/13/2009
Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile
Virus from Donors of Whole Blood and Blood Components Intended for Transfusion (PDF - 68KB)
11/6/2009
Draft Guidance for Industry and FDA Staff - Investigational New Drug Applications (INDs) for
Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic
Reconstitution for Specified Indications (PDF - 91KB)
10/2009
Guidance for Industry - Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood
Intended for Hematopoietic Reconstitution for Specified Indications (PDF - 462KB)
10/2009
Guidance for Industry - Recommendations for Management of Donors at Increased Risk for Human
Immunodeficiency Virus Type 1 (HIV-1) Group O Infection
8/2009
Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19
Transmission by Plasma-Derived Products
7/28/2009
Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of
Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and
Cellular and Tissue-Based Products
3/2009
Assay Migration Studies for In Vitro Diagnostic Devices
1/5/2009
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Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune
Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency
7/17/2008
Draft Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of
Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc)
5/20/2008
Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West
Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human
Cells, Tissues, and Cellular and Tissue-Based Products (HCT[sol]Ps)
4/25/2008
Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods
12/17/2007
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood
Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
11/29/2007
Guidance for Industry: Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B
Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source
Plasma and Source Leukocytes
11/21/2007
Draft Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility
10/26/2007
Guidance for Industry: ``Lookback'' for Hepatitis C Virus (HCV): Product Quarantine, Consignee
Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor
Test Results Indicating Infection with HCV
8/24/2007
Guidance for Industry: Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance
Genotype Assay
8/08/2007
Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors Participating in
Plasmapheresis and Immunization Programs
6/20/2007
Draft Guidance for Industry: ``Computer Crossmatch'' (Electronic Based Testing for the Compatibility
between the Donor's Cell Type and the Recipient's Serum or Plasma Type)
6/20/2007
Guidance for Industry: Implementation of Acceptable Full-Length Donor History Questionnaire and
Accompanying Materials for Use in Screening Donors of Blood and Blood Components
10/27/2006
Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments
10/18/2006
Guidance for Industry: Bar Code Label Requirements - Questions and Answers
10/5/2006
Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component
Container Labels
9/22/2006
United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components
Using ISBT 128 (PDF - 1665KB)
9/22/2006
Guidance for Industry: Implementing a Collection Program for Source Plasma Containing Disease-
Associated and Other Immunoglobulin (IgG) Antibodies
8/08/2006
Draft Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to
``Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of
Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products''
8/08/2006
Draft Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-
1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry
7/19/2005
Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of
Known or Suspected West Nile Virus Infection
6/23/2005
Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor
Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-
Based Products (HCT[sol]Ps)
11/24/2004
Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
11/30/2004
Draft Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as
Red Blood Cell Substitutes
10/28/2004
Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of
Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and
Appropriately Reduce the Risk of Transmission of HIV-1 and HCV
10/21/2004
Questions and Answers on ``Guidance for Industry: Revised Preventive Measures to Reduce the Possible
Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood
and Blood Products''
1/22/2004
Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of
West Nile Virus - Guidance for Industry and FDA Staff
10/30/2003
Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion
9/22/2003
Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood
Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS
9/16/2003
[[Page 48185]]
Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-
Administered Questionnaires
7/3/2003
Draft Guidance for Industry: Revised Recommendations for Donor and Product Management Based on
Screening Tests for Syphilis
6/25/2003
Question and Answer on FDA Guidance Entitled ``Recommendations for the Assessment of Donor
Suitability and Blood and Blood Product Safety in Cases of Suspected and Probable Severe Acute Respiratory
Syndrome (SARS) or Exposure to SARS''
4/25/2003
Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood Product
Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS
4/17/2003
Questions and Answers on FDA Guidance Entitled ``Recommendations for Deferral of Donors and
Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia
Virus) and Certain Contacts of Smallpox Vaccine Recipients''
1/15/2003
Guidance for Industry: Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood
and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox
Vaccine Recipients
12/30/2002
Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of
Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Intimate Contacts
2/1/2002
General Principles of Software Validation; Final Guidance for Industry and FDA Staff
1/11/2002
Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of
Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products
1/9/2002
Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices
11/22/2001
Guidance for Industry - Recommendations for Assessment of Donor Suitability and Blood and Blood
Product Safety in Cases of Possible Exposure to Anthrax
10/17/2001
Guidance for Industry: Variances for Blood Collection from Individuals with Hereditary
Hemochromatosis
8/22/2001
Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood
Components Intended for Transfusion or for Further Manufacture
8/07/2001
Guidance for FDA Reviewers: Premarket Notification Submissions for Blood and Plasma Warmers
7/19/2001
Guidance for FDA Reviewers: Premarket Notification Submissions for Transfer Sets (Excluding Sterile
Connecting Devices)
7/19/2001
Guidance for FDA Reviewers: Premarket Notification Submissions for Empty Containers for the
Collection and Processing of Blood and Blood Components
7/19/2001
Guidance for Industry: Revised Recommendations Regarding Invalidation of Test Results of Licensed and
510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors
7/11/2001
Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing
3/29/2001
Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods
Technical Correction February 2001
2/13/2001
Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components
Intended for Transfusion
1/23/2001
Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric
Blood Specimens
6/23/2000
Draft Guidance for Industry: Recommendations for Donor Questioning Regarding Possible Exposure to
Malaria
6/8/2000
Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of
Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Contacts
12/23/1999
Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic
Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2
12/14/1999
Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug
Regulations (PDF - 26KB)
7/15/1999
Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured
for Commercial Use
5/20/1999
Draft Guidance for Industry For Platelet Testing and Evaluation of Platelet Substitute Products
5/20/1999
Guidance for Industry For the Submission of Chemistry, Manufacturing and Controls and Establishment
Description Information for Human Blood and Blood Components Intended for Transfusion or for Further
Manufacture and For the Completion of the Form FDA 356h ``Application to Market a New Drug, Biologic or an
Antibiotic Drug for Human Use''
5/10/1999
Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and
Establishment Description Information for a Biological In Vitro Diagnostic Product
3/8/1999
[[Page 48186]]
Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment
Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products
2/17/1999
Withdrawal of ``Guidance for Industry: Supplemental Testing and the Notification of Consignees of
Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV)''
9/8/1998
Guidance for Industry: Errors and Accidents Regarding Saline Dilution of Samples Used for Viral
Marker Testing
6/11/1998
Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results
for Antibody to Hepatitis C Virus (Anti-HCV)
3/20/1998
Guidance for Industry: Year 2000 Date Change for Computer Systems and Software Applications Used in
the Manufacture of Blood Products
1/08/1998
Guidance for Industry: Donor Screening for Antibodies to HTLV-II
8/15/1997
Guidance for Industry: Changes to an Approved Application: Biological Products (PDF - 39KB)
7/1997
Guideline for Quality Assurance in Blood Establishments (PDF - 77KB)
7/11/1995
Draft Recommended Methods for Blood Grouping Reagents Evaluation (PDF - 2101KB)
3/1992
Draft Recommended Methods for Evaluating Potency, Specificity, and Reactivity of Anti-Human Globulin
(PDF - 1161KB)
3/1992
Draft Points to Consider in the Design and Implementation of Field Trials for Blood Grouping Reagents
and Anti-Human Globulin (PDF - 211KB)
1992
Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious
Disease Markers (``High Risk'' Donors) (PDF - 176KB)
10/26/1989
Draft Points to Consider in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect
Antibodies to the Human Immunodeficiency Virus Type 1 (PDF - 1784KB)
8/08/1989
Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test For
Human and Animal Parenteral Drugs, Biological Products and Medical Devices (PDF - 2874KB)
12/1987
Guideline for the Uniform Labeling of Blood and Blood Components (PDF - 1189KB)
8/1985
Guidelines for Immunization of Source Plasma (Human) Donors with Blood Substances (PDF - 368KB)
6/1980
Cellular & Gene Therapy Guidance Documents
Draft Guidance for Industry and FDA Staff - Investigational New Drug Applications (INDs) for
Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic
Reconstitution for Specified Indications (PDF - 91KB)
10/2009
Guidance for Industry - Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood
Intended for Hematopoietic Reconstitution for Specified Indications (PDF - 462KB)
10/2009
Draft Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines
9/2009
Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products
09/2009
Draft Guidance for Industry: Somatic Cell Therapy for Cardiac Disease
03/2009
Draft Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products
10/9/2008
Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control
(CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
4/9/2008
Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control
(CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs)
4/9/2008
Draft Guidance for Industry: Validation of Growth-Based Rapid Microbiological Methods for Sterility
Testing of Cellular and Gene Therapy Products
2/11/2008
Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and
Tissue-Based Products
8/8/2007
Draft Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace
Knee Cartilage
7/6/2007
Guidance for Industry: Gene Therapy Clinical Trials - Observing Subjects for Delayed Adverse Events
11/28/2006
Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in
Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using
Retroviral Vectors
11/28/2006
Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy
3/30/1998
[[Page 48187]]
Guidance for the Submission of Chemistry, Manufacturing, and Controls Information and Establishment
Description for Autologous Somatic Cell Therapy Products (TXT - 59KB)
01/1997
CMC & GMP
Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug
Products Terminally Sterilized by Moist Heat Processes (PDF - 73KB)
2/2010
Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics (PDF - 91KB)
11/2008
Process Validation: General Principles and Practices (PDF - 194KB)
11/2008
Current Good Manufacturing Practice for Phase 1 Investigational Drugs (PDF - 132KB)
7/2008
Guidance for Industry: Manufacturing Biological Intermediates and Biological Drug Substances Using
Spore-Forming Microorganisms (PDF - 184KB)
9/6/2007
Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (PDF -
443KB)
9/2006
Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling (PDF
253KB)
9/2006
Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (PDF -
110KB)
1/2006
Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (PDF - 230KB)
5/2005
Sterile Drug Products Produced by Aseptic Processing--Current Good Manufacturing Practice (PDF -
734KB)
9/2004
Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing,
and Controls Information (PDF - 82KB)
9/2003
Comparability Protocols--Chemistry, Manufacturing, and Controls Information (PDF - 240KB)
2/2003
CVM GFI 153 Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use
in Humans and Animals (PDF - 88KB)
9/2002
Container Closure Systems for Packaging Human Drugs and Biologics--Questions and Answers (PDF - 15KB)
5/2002
IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information (PDF -
30KB)
5/2001
Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing (PDF - 30KB)
3/2001
Analytical Procedures and Methods Validation Chemistry, Manufacturing, and Controls Documentation
(PDF - 91KB)
8/2000
Possible Dioxin/PCB Contamination of Drug and Biological Products (PDF - 8KB)
8/1999
Container Closure Systems for Packaging Human Drugs and Biologics (PDF - 164KB)
5/1999
Environmental Assessment of Human Drug and Biologics Applications (PDF - 188KB)
7/1998
Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients (PDF - 150KB)
3/1998
Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a
Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use (PDF - 44KB)
8/1996
Submission Documentation for Sterilization Process Validation in Applications for Human and
Veterinary Drug Products (PDF - 57KB)
11/1994
Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test For
Human and Animal Parenteral Drugs, Biological Products and Medical Devices (PDF - 2874KB)
12/1987
Guidance on Alternatives to Lot Release for Licensed Biological Products (PDF - 305KB)
7/14/1993
Clinical
Drug-Induced Liver Injury: Premarketing Clinical Evaluation (PDF - 206KB)
7/2009
Postmarketing Studies and Clinical Trials--Implementation of Section 505(o) of the Federal Food,
Drug, and Cosmetic Act (PDF - 173KB)
7/2009
The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug
Application (PDF - 421KB)
6/2009
Animal Models--Essential Elements to Address Efficacy Under the Animal Rule (PDF - 135KB)
2/2009
Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs--Improving
Human Subject Protection (PDF - 61KB)
1/2009
Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (PDF - 145KB)
5/2007
Computerized Systems Used in Clinical Trials (PDF - 53KB)
5/2007
[[Page 48188]]
Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling (PDF
253KB)
9/2006
Chronic Cutaneous Ulcer and Burn Wounds--Developing Products for Treatment (PDF - 205KB)
6/2006
Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens
that are Not Individually Identifiable (PDF Version) (PDF - 65KB)
4/25/2006
The Establishment and Operation of Clinical Trial Data Monitoring Committees for Clinical Trial
Sponsors
3/2006
Using a Centralized IRB Review Process in Multicenter Clinical Trials (PDF - 87KB)
3/2006
Reports on the Status of Postmarketing Study Commitments--Implementation of Section 130 of the Food
and Drug Administration Modernization Act of 1997 (PDF - 456KB)
2/2006
Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products--Content and
Format (PDF - 127KB)
2/2006
Collection of Race and Ethnicity Data in Clinical Trials (PDF - 70KB)
9/2005
Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult
Healthy Volunteers (PDF - 702KB)
7/2005
Evaluating the Risks of Drug Exposure in Human Pregnancies (PDF - 3151KB)
4/2005
Premarketing Risk Assessment (PDF - 88KB)
3/2005
Development and Use of Risk Minimization Action Plans (PDF - 225KB)
3/2005
Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (PDF - 220KB)
3/2005
Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling (PDF -
363KB)
2/2005
Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (PDF
- 211KB)
12/2004
Available Therapy (PDF - 176KB)
7/2004
Vaccinia Virus--Developing Drugs to Mitigate Complications from Smallpox Vaccination (PDF - 139KB)
3/2004
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (PDF -
40KB)
1/2004
IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of
Cancer (PDF - 188KB)
1/2004
Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices (PDF Version)
(PDF - 389KB)
7/2003
Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact
on Dosing and Labeling (PDF - 222KB)
5/2003
Exposure-Response Relationships--Study Design, Data Analysis, and Regulatory Applications (PDF -
221KB)
4/2003
Establishing Pregnancy Exposure Registries (PDF - 268KB)
8/2002
Special Protocol Assessment (PDF - 36KB)
5/2002
FDA Guidance on Clinical Trial Data Monitoring Committees (DMC's) Open Public Meeting (PDF - 394KB)
11/2001
Cancer Drug and Biological Products - Clinical Data in Marketing Applications (PDF - 39KB)
10/2001
IDE Financial Disclosure
Acceptance of Foreign Clinical Studies (PDF - 12KB)
3/2001
Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) (PDF - 56KB)
11/2000
Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (PDF - 26KB)
10/2000
Pediatric Oncology Studies In Response to a Written Request (PDF - 30KB)
6/2000
In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations
for Dosing and Labeling (PDF - 44KB)
11/2009
Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment
of Osteoarthritis (PDF - 40KB)
7/1999
Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of
Rheumatoid Arthritis (RA) (PDF - 369KB)
2/1999