FDA’s mission is to ensure that safe and effective new drugs are available as quickly as possible and that drugs already marketed remain safe and of the highest quality for as long as the drugs remain on the U.S. market. As part of this authority, industry should be on notice that FDA intends to vigorously enforce requirements that sponsors conduct postmarket studies and clinical trials.
In 2007, Congress passed the Food and Drug Administration Amendments Act of 2007 (FDAAA), which amended the Food, Drug, and Cosmetic Act (the Act) to provide the agency with substantial new authorities to ensure the safe and appropriate use of drugs. One of these provisions gives FDA the authority to require drug companies to conduct postmarketing studies or clinical trials – known as postmarketing requirements (PMRs). FDA may require these PMRs either at the time of approval or after approval if the agency becomes aware of new safety information that could indicate a serious potential risk associated with the use of the drug (section 505(o)(3) of the Act).
FDA may require postmarketing studies and clinical trials:
- To assess a known serious risk related to the use of the drug;
- To assess signals of a serious risk related to the use of the drug; and
- To identify an unexpected serious risk when available data indicate the potential for serious risk.
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