Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The purpose of this guidance is to assist sponsors in the clinical development of drugs […]

The list of DMFs, which is updated quarterly, contains DMFs RECEIVED by March 31, 2024, for which acknowledgment letters were sent before April 10, 2024. The […]

Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) […]

Helping Guide the Way for New Medicines Innovative drugs often mean new treatment options for patients and advances in health care for the American public. When […]

The FDA Office of Generic Drugs follows a rigorous review process to make sure that, compared to the brand-name (or innovator) medications, the proposed generic medications: […]

For Immediate Release: April 09, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Friday, […]

Biosimilars Basics for Patients Approval, labeling, side effects, and safety Using Fat-Dissolving Injections That Are Not FDA Approved Can Be Harmful Buying & Using Medicine Safely […]

Notice to Industry: Bioresearch Monitoring Information System (BMIS) Data In order to foster transparency and encourage information sharing within the clinical research community, FDA’s Center for […]

Summary Company Announcement Date: July 20, 2020 FDA Publish Date: July 20, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Methanol Contamination Company […]