[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR601.70]

[Page 43-45]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 601_LICENSING--Table of Contents
 
                     Subpart G_Postmarketing Studies
 
Sec. 601.70  Annual progress reports of postmarketing studies.

    Source: 65 FR 64618, Oct. 30, 2000, unless otherwise noted.


    (a) General requirements. This section applies to all required 
postmarketing studies (e.g., accelerated approval clinical benefit 
studies, pediatric studies) and postmarketing studies that an applicant 
has committed, in writing, to conduct either at the time of approval of 
an application or a supplement to an application, or after approval of 
an application or a supplement. Postmarketing studies within the meaning 
of this section are those that concern:
    (1) Clinical safety;
    (2) Clinical efficacy;
    (3) Clinical pharmacology; and
    (4) Nonclinical toxicology.
    (b)What to report. Each applicant of a licensed biological product 
shall submit a report to FDA on the status of postmarketing studies for 
each approved product application. The status of these postmarketing 
studies shall be reported annually until FDA notifies the applicant, in 
writing, that the

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agency concurs with the applicant's determination that the study 
commitment has been fulfilled, or that the study is either no longer 
feasible or would no longer provide useful information. Each annual 
progress report shall be accompanied by a completed transmittal Form 
FDA-2252, and shall include all the information required under this 
section that the applicant received or otherwise obtained during the 
annual reporting interval which ends on the U.S. anniversary date. The 
report must provide the following information for each postmarketing 
study:
    (1) Applicant's name.
    (2) Product name. Include the approved product's proper name and the 
proprietary name, if any.
    (3) Biologics license application (BLA) and supplement number.
    (4) Date of U.S. approval of BLA.
    (5) Date of postmarketing study commitment.
    (6) Description of postmarketing study commitment. The description 
must include sufficient information to uniquely describe the study. This 
information may include the purpose of the study, the type of study, the 
patient population addressed by the study and the indication(s) and 
dosage(s) that are to be studied.
    (7) Schedule for completion and reporting of the postmarketing study 
commitment. The schedule should include the actual or projected dates 
for submission of the study protocol to FDA, completion of patient 
accrual or initiation of an animal study, completion of the study, 
submission of the final study report to FDA, and any additional 
milestones or submissions for which projected dates were specified as 
part of the commitment. In addition, it should include a revised 
schedule, as appropriate. If the schedule has been previously revised, 
provide both the original schedule and the most recent, previously 
submitted revision.
    (8) Current status of the postmarketing study commitment. The status 
of each postmarketing study should be categorized using one of the 
following terms that describes the study's status on the anniversary 
date of U.S. approval of the application or other agreed upon date:
    (i) Pending. The study has not been initiated, but does not meet the 
criterion for delayed.
    (ii) Ongoing. The study is proceeding according to or ahead of the 
original schedule described under paragraph (b)(7) of this section.
    (iii) Delayed. The study is behind the original schedule described 
under paragraph (b)(7) of this section.
    (iv) Terminated. The study was ended before completion but a final 
study report has not been submitted to FDA.
    (v) Submitted. The study has been completed or terminated and a 
final study report has been submitted to FDA.
    (9) Explanation of the study's status. Provide a brief description 
of the status of the study, including the patient accrual rate 
(expressed by providing the number of patients or subjects enrolled to 
date, and the total planned enrollment), and an explanation of the 
study's status identified under paragraph (b)(8) of this section. If the 
study has been completed, include the date the study was completed and 
the date the final study report was submitted to FDA, as applicable. 
Provide a revised schedule, as well as the reason(s) for the revision, 
if the schedule under paragraph (b)(7) of this section has changed since 
the previous report.
    (c) When to report. Annual progress reports for postmarketing study 
commitments entered into by applicants shall be reported to FDA within 
60 days of the anniversary date of the U.S. approval of the application 
for the product.
    (d) Where to report. Submit two copies of the annual progress report 
of postmarketing studies to the Center for Biologics Evaluation and 
Research or Center for Drug Evaluation and Research (see mailing 
addresses in Sec. 600.2 of this chapter).
    (e) Public disclosure of information. Except for the information 
described in this paragraph, FDA may publicly disclose any information 
concerning a postmarketing study, within the meaning of this section, if 
the agency determines that the information is necessary to identify an 
applicant or to establish the status of the study including the reasons, 
if any, for failure to conduct, complete, and report the

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study. Under this section, FDA will not publicly disclose trade secrets, 
as defined in Sec. 20.61 of this chapter, or information, described in 
Sec. 20.63 of this chapter, the disclosure of which would constitute an 
unwarranted invasion of personal privacy.

[65 FR 64618, Oct. 30, 2000, as amended at 70 FR 14984, Mar. 24, 2005]