[6/20/2024] Today, FDA issued a draft guidance for industry “Considerations for Demonstrating Interchangeability with a Reference Product: Update.” This draft guidance describes considerations regarding a switching […]

Docket Number: FDA-2017-D-0154 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance is intended to assist […]

FDA-approved biosimilars are safe and effective biologic medications that are highly similar to biologic medications already approved by FDA – called “reference products.” There are no […]

For Immediate Release: June 18, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

FDA is committed to protecting the health of the American public by holding approved products to high standards of quality, safety, and efficacy.  FDA has issued […]

[06/18/2024] FDA is notifying sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) that clinical and bioanalytical studies conducted by Synapse Labs Pvt. […]

Thank you for taking the time to participate in a Patient Listening Session! Patient Listening Sessions help FDA understand what is important to the patient community […]

FDA considers advancing the availability of evidence-based guidelines for opioid analgesics and other medications with abuse potential a high-impact opportunity to support the safe use of […]