Introduction

This section is intended to provide information to the public on postmarketing requirements and commitments. The phrase postmarketing requirements and commitments refers to studies and clinical trials that sponsors conduct after approval to gather additional information about a product's safety, efficacy, or optimal use. Some of the studies and clinical trials may be required; others may be studies or clinical trials a sponsor has committed to conduct.

Postmarketing requirements (PMRs) include studies and clinical trials that sponsors are required to conduct under one or more statutes or regulations. 

Postmarketing commitments (PMCs) are studies or clinical trials that a sponsor has agreed to conduct, but that are not required by a statute or regulation. In the past, we have used the word commitment to cover both required and not required studies and clinical trials. Now, because commitments and requirements are treated differently under the law, we are using terminology that distinguishes between studies and clinical trials that are required and those that a sponsor agrees to conduct that are not required.

Commitments containing proprietary information (e.g., those to evaluate chemistry or manufacturing and control issues) are not included in the database.

What Studies or Clinical Trials Can Be Required Today?

The 2007 Food and Drug Administration Amendments Act (FDAAA) specifically provides FDA with authority to require drug manufacturers to conduct postmarket safety studies and clinical trials to assess possible serious risks associated with the drugs. The studies and clinical trials that can be required under FDAAA join the types of studies and clinical trials that FDA could require before FDAAA. Before FDAAA, FDA could require the following studies or clinical trials:

• Postmarketing studies or clinical trials to demonstrate clinical benefit for drugs approved under the accelerated approval requirements in 21 CFR 314.510 and 21 CFR 601.41
• Deferred pediatric studies (21 CFR 314.55(b) and 601.27(b)), where studies are required under the Pediatric Research Equity Act (PREA)
• Studies or clinical trials to demonstrate safety and efficacy in humans that must be conducted at the time of use of products approved under the Animal Efficacy Rule (21 CFR 314.610(b)(1) and 601.91(b)(1))

Now, under FDAAA, postmarketing studies and clinical trials also can be required to:

• Assess a known serious risk related to the use of the 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

What Has Changed Since the Enactment of FDAAA?

This section contains information about postmarketing studies and clinical trials previously reported under the Modernization Act (both requirements and commitments), and it also contains information about studies and clinical trials required under FDAAA. Some changes have been made.

• PMR refers to postmarketing requirements, studies or clinical trials the sponsor is required to conduct
• PMC now refers to postmarketing commitments, studies or clinical trials to which sponsors commit but that they are not required to conduct
• Changes have been made to the searchable database of information on postmarketing studies and clinical trials for drugs and biological products.
• Frequently asked questions have been updated to reflect the changes resulting from FDAAA.