The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
Postmarketing Requirements 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. For more information please visit: Postmarketing Requirements
The Small Business Assistance (SBA) program in the Center for Drug Evaluation and Research (CDER) provides guidance and information to regulated domestic and international small pharmaceutical business through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the SBA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM – 4:30PM. Please take our CDER Small Business survey: https://www.surveymonkey.com/s/cdersmallbusiness
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