Real-World Evidence Submissions to the Center for Drug Evaluation and Research
As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA VII), FDA committed to reporting aggregate and anonymized information on submissions.
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Common Questions about Medication Health Fraud
Find answers to the most asked questions about medication health fraud and how to identify scams when buying products. -
Bio Wellness 444 LLC – 709333 – 05/30/2025
Unapproved New Drugs/Misbranded -
Laboratoire Druide Inc. – 705517 – 05/29/2025
CGMP/Finished Pharmaceuticals/Adulterated -
Sprout Pharmaceuticals, Inc. – 709942 – 05/29/2025
False & Misleading Claims/Misbranded -
American Behavioral Research Institute, LLC – 705629 – 04/30/2025
Clinical Investigator (Sponsor) -
Amish Origins Management, LLC – 704166 – 05/29/2025
CGMP/Finished Pharmaceuticals/Adulterated -
Sexual Enhancement and Energy Product Notifications
Learn about the warnings for sexual enhancement and energy products that contain hidden drugs and other hidden ingredients. -
Sleep, Skin and Bodybuilding Product Notifications
Learn about the warnings for sleep, skin and bodybuilding products that contain hidden drugs and other hidden ingredients. -
CDER Quality Management Maturity
FDA has proposed the development of a rating system that will help incentivize drug manufacturers to achieve Quality Mangement Maturity at their facilities. -
Recently Issued Guidance Documents
This page lists Recently Issued CBER and Cross-Center Guidance Documents. -
Drug Safety and Risk Management Advisory Committee Roster
This page contains the DSARM roster, which lists the current members and the current number of vacancies for the committee.