Postmarketing Requirements and Commitments: Frequently Asked Questions (FAQ)
- Why is FDA providing this Web site?
- What information does the Postmarketing Requirements and Commitments Web site include?
- Where does the information on this site come from?
- How often will the Web site be updated?
- Can a product have more than one requirement or commitment?
- Are NDA and ANDA applicants required to submit an annual report?
- Are BLA applicants required to submit an annual report?
- When and how often must an applicant submit an annual status report to FDA?
- Are there new reporting requirements under FDAAA?
- How soon will information from the latest annual status report appear on the Web site?
- How can I search the Postmarketing Requirements and Commitments database?
- What will I see in my search results?
- What is meant by "Required Under: Accelerated Approval" in the search results display?
- What is meant by "Required Under: Animal Efficacy Rule" in the search results display?
- What is meant by "Required Under: Pediatric Research Equity Act" in the search results display?
- What is meant by “Required Under: FDAAA Section 505(o)(3)”?
- Why do some products have an "Final Report Due Date" while others do not?
- What do brackets [ ] mean in the text of the requirement or commitment?
- Does the site include an explanation of the status for a particular requirement or commitment?
- What do the "Postmarketing Requirements and Commitments Status" categories mean?
- How can I get a copy of a postmarketing requirement or commitment protocol or final report?
- How can I download a data file containing the information displayed on this Web site?
- Whom can I contact if I have more questions?
Section 130(a) of Title I of the Food and Drug Administration Section 130(a) of Title I of the Food and Drug Administration Modernization Act of 1997 ("the Modernization Act") became law on November 21, 1997, and added section 506B (Reports of Postmarketing Studies) to the Federal Food, Drug, and Cosmetic Act ("the Act") (21 U.S.C. 356b). This provision requires applicants to report to FDA annually on the progress of postmarketing requirements/commitments and for FDA to make certain information available to the public. back to FAQ list
The site does not include requirements or commitments involving proprietary information (e.g., to evaluate chemistry or manufacturing and control issues).
The information included on this site is based on FDA's internal postmarketing requirements and commitments database. FDA continuously verifies the information contained in the database to ensure its accuracy. The information on the Web site, including additions and status changes, is updated quarterly. (See question number 4.) To find out what information you can retrieve from this site, see question number 11. back to FAQ list
Information about postmarketing requirements/commitments comes from Agency letters and from annual status reports submitted by applicants. Information is verified for accuracy before it is posted on the Web site. back to FAQ list
The Web site is updated in January, April, July, and October. back to FAQ list
Yes, there can be more than one requirement and/or commitment related to the approval of an original new drug application (NDA) or biologics license application (BLA), as well as more than one requirement and/or commitment related to subsequent supplemental application approvals. back to FAQ list
6. Are NDA and ANDA applicants required to submit an annual report?
21 CFR 314.81 requires an applicant to submit an annual report for every approved NDA and every abbreviated new drug application (ANDA). back to FAQ list
The regulations require annual reports for products marketed under a BLA for:
- certain changes made to the application (21 CFR 601.12(d))
- summaries on submissions related to pediatric studies (21 CFR 601.28)
- status reports on postmarketing requirements/commitments related to clinical safety, clinical efficacy, clinical pharmacology, or nonclinical toxicology (21 CFR 601.70)
Routine annual reports, such as those required under NDA or ANDA regulations, are not mandatory for licensed biological products. back to FAQ list
8. When and how often must an applicant submit an annual status report to FDA?
An applicant must submit an annual report each year within 60 days after the anniversary date of U.S. approval of the application. The annual status report is required for all applications with open requirements and commitments until we notify the applicant, in writing, that all postmarketing requirements/commitments established under the application(s) have either been fulfilled or that the applicant is released from the requirements/commitments. The annual report due date will be based upon the anniversary date for the original application approval date. Separate annual reports are not required for supplemental applications. An annual status report can address more than one requirement/commitment for a particular NDA, BLA, or ANDA. back to FAQ list
Yes, section 505(o)(3)(E)(ii) of the FDCA requires an applicant to report periodically on the status of any study or clinical trial required under this section. This section also requires an applicant to periodically report to FDA on the status of any study or clinical trial otherwise undertaken to investigate a safety issue. FDA will consider the submission of an annual report under section 506B and 21 CFR 314.81(b)(2)(vii) to satisfy the periodic reporting requirement under section 505(o)(3)(E)(ii) provided that the report includes the elements listed in section 505(o) and 21 CFR 314.81(b)(2)(vii). To comply with section 505(o), an annual report must also include a report on the status of any study or clinical trial otherwise undertaken to investigate a safety issue. Failure to submit an annual report for studies or clinical trials required under section 505(o) on the date required will be considered a violation of FDCA section 505(o)(3)(E)(ii) and could result in enforcement action. back to FAQ list
Updates to postmarketing requirements/commitments based on new information from the annual status report may not always appear in the same quarter they are submitted to the Agency. Publishing delays may occur, depending on when an annual status report is submitted and when the information is verified. The current information included on this site is based on the FDA's postmarketing requirements/commitments database and will change as data are updated quarterly. (See question number 4.) back to FAQ list
- Center: Select CDER or CBER or both.
- Applicant: Enter the name (or part of the name) of a company.
- Product: Enter the name or active ingredient (or part of the name or ingredient).
- NDA/ANDA/BLA Number: Enter the entire number. Do not include a hyphen in the application number.
- Requirement/Commitment Status: Select from the menu; the default is "All Statuses."
- Required Under: Check specific types of postmarketing requirements if you would like to limit your search to them.
- NDA/ANDA/BLA Approval Date: Enter a range of dates.
You can limit the number of records you retrieve by providing very specific information (such as the NDA/ANDA/BLA number), or you can retrieve more records by searching on more general terms (such as requirement/commitment status = "ongoing"). However, all search fields are optional.
If your search criteria match some information in a record, you will see a screen telling you how many application or supplement records you retrieved. One application/supplement record appears on each page, and it will have one or more requirements/commitments listed below it.
The following fields can appear on a Search Results page:
- Applicant: The name of the applicant (e.g., a company name)
- Product: The name of the product followed by the active ingredient
- NDA/ANDA/BLA Number
- Supplement Number: This appears only for supplemental applications
- NDA/ANDA/BLA Approval Date: The date the product was originally approved by FDA
- Annual Report Due Date: The date the next report is due
- Annual Report Received: The date FDA received the latest annual report
- Requirement/Commitment Number: This is the number as it appears in Agency letters. It does not refer to the requirement’s or commitment's position on the search results page.
- Required Under: This appears only for required postmarketing studies or clinical trials. (See questions number 13, 14, 15 and 16)
- Final Report Date: This appears only for studies/clinical trials where this information is available. (See question number 17)
- Requirement/Commitment Description
- Current Status: There are seven categories: "pending," "ongoing," "delayed," "terminated," "submitted, "fulfilled" and "released." (See the definitions of status categories)
Explanation of Status: This appears for pediatric requirements (all statuses) and for all other requirements/commitments with “delayed” or “terminated” status. (See question number 20)
On December 11, 1992, FDA published the final rule to accelerate the approval of new drugs for serious and life-threatening diseases when the drug provides meaningful therapeutic benefit over existing products. Under 21 CFR 314.510 and 21 CFR 601.41, FDA may approve drugs based on surrogate endpoints that reasonably predict that a drug provides clinical benefit. This clinical benefit is then confirmed through additional human studies or clinical trials that will be completed after marketing approval. back to FAQ list
On May 31, 2002, FDA published the final rule to allow use of animal data for evidence of the drug’s effectiveness for certain conditions when the drug cannot be ethically or feasibly tested in humans. In these situations, certain new drug and biological products used to reduce or prevent the toxicity of chemical, biological, radiological, or nuclear substances may be approved for marketing based on evidence of effectiveness derived from appropriate studies in animals and any additional supporting data. Under CFR 314.610(b)(1) and 601.91(b)(1), the applicant must conduct postmarketing studies or clinical trials to verify and describe the drug’s clinical benefit when such studies or clinical trials are feasible and ethical. Such postmarketing studies or clinical trials may not be feasible until an exigency arises that necessitates use of the product. back to FAQ list
On December 3, 2003, the President signed the Pediatric Research Equity Act (PREA) of 2003 to improve the quality of pediatric information in drug labeling, PREA was reauthorized on September 27, 2007. This legislation provides FDA with explicit authority to require applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration to include pediatric studies or clinical trials. The legislation also authorizes FDA to require pediatric studies or clinical trials of marketed drugs that are not adequately labeled for children after other opportunities to obtain such studies or clinical trials on a voluntary basis have been exhausted. The requirement for such studies or clinical trials may be waived if necessary studies or clinical trials in children are impossible, there is strong evidence suggesting the drug will not be effective or safe in children, the drug does not represent a meaningful therapeutic benefit over existing therapies for children, or the drug is not likely to be used in a substantial number of children. Such studies or clinical trials may also be deferred if the drug is ready for approval in adults before pediatric studies or clinical trials are completed or due to concerns about the safety or effectiveness of the drugs in pediatric populations. When such studies or clinical trials are deferred, they will be reported as postmarketing requirements under 21 CFR 314.81 and 601.70. back to FAQ list
On September 27, 2007, the President signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85). Section 901, in Title IX of FDAAA, created section 505(o) of the Federal Food, Drug, and Cosmetic Act (the Act), which authorizes FDA to require certain studies and clinical trials1 for prescription drugs and biological products approved under section 505 of the Act or section 351 of the Public Health Service Act. This new authority became effective on March 25, 2008. Postmarketing studies or clinical trials may be required to:
- Assess a known serious risk related to the use of a drug
- Assess signals of serious risk related to the use of the drug
- Identify an unexpected serious risk when available data indicate the potential for a serious risk
1. FDAAA makes a new distinction between study and clinical trial. Previous laws, regulations, and practice have used the terms studies and trials interchangeably. Although Section 506B uses studies to describe commitments that must be reported annually, this term also included clinical trials.
An applicant may have included a schedule for completing a study(ies) or clinical trial(s) with their first annual status report after the implementation of section 506B of the Act, but FDA did not begin capturing "Final Report Due Dates" in the database until April 2001. If you do not see a date in the "Final Report Due Date" field, that information is currently not available for that postmarketing requirement/commitment. back to FAQ list
Under the Freedom of Information Act (5 U.S.C. 552) (FOIA), certain information in Agency records may not be released to the public. The brackets in the text of the postmarketing requirements/commitments mean that some information was removed — or redacted — from the requirement/commitment because the information may not be released under FOIA. . back to FAQ list
The "Explanation of Status" is a brief explanation about how the study/clinical trial is progressing in reference to the original study schedule. The explanation of status is displayed on the Web site for pediatric studies (all statuses) and for all other requirements/commitments with “delayed” or “terminated” statuses. If the explanation of status provided by the sponsor in their annual status report has not yet been verified by FDA, the text for this field will read "The explanation of status has not yet been verified." If the sponsor has not provided an explanation of status in their annual status report, the text for this field will read "An explanation of status was not provided in the annual status report." back to FAQ list
Pending: The study/clinical trial has not been initiated (i.e., no subjects have been enrolled or animals dosed), but does not meet the criterion for delayed (i.e., the original projected date for initiation of patient accrual or initiation of animal dosing has not passed).
Ongoing: The study/clinical trial is proceeding according to, or is ahead of, the original schedule. The FDA considers a study/clinical trial to be ongoing until a final report is submitted to the FDA, as long as the activities are proceeding according to the original schedule. If patient accrual or animal dosing has started but is not complete, and the projected date for completion of that milestone has passed, the study/clinical trial should be categorized as delayed.
Delayed: The progression of the study/clinical trial is behind the original schedule. Delays can occur in any phase of the study/clinical trial, including patient enrollment, analysis of results, or submission of the final report to the FDA. While the original schedule—not a revised schedule—serves as the basis for defining a study/clinical trial as delayed, each phase of the study/clinical trial will be considered in its own right. If the applicant has one delayed phase, but gets back on schedule during the next phase, the delayed status will no longer apply.
Terminated: The applicant ended the study/clinical trial before completion and has not yet submitted a final report to the FDA.
Submitted: The applicant has concluded or terminated the study/clinical trial and has submitted a final report to the FDA, but FDA has not yet notified the applicant in writing that the requirement/commitment has been fulfilled or that the requirement/commitment has been released.
Fulfilled: The applicant has submitted the final report for the requirement/commitment, and, upon review of the final report, FDA is satisfied that the applicant has met the terms of the requirement/commitment.
Released: FDA has informed the applicant that it has been released from its requirement/commitment to conduct the postmarketing study/clinical trial because it is either no longer feasible or would no longer provide useful information.
Note: The fulfilled and released requirements/commitments will be displayed on the Web site for not more than 1 year from the date of fulfillment or release.
Protocols and final reports can be requested either directly from the applicant or from FDA under the Freedom of Information Act (5 U.S.C. 552) (FOIA). Because information contained in these documents may be proprietary in nature, your request may be denied or information in the documents may be redacted. Certain information regarding postmarketing studies and clinical trials may also be obtained from ClinicalTrials.gov.. back to FAQ list
To obtain a data file of all of the information posted on this Web site, click on the “Downloadable Database File” hyperlink at the bottom of the search screen and follow the instructions provided. This will allow you to download a compressed data file of the postmarketing requirement/commitment information publicly posted on this Web site. back to FAQ list
If you have any questions or comments related to Postmarketing Requirements or Commitments or this Web site, please send them to the Postmarketing Requirements and Commitments Coordinator at email@example.com.