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 […]

IMPACT  INNOVATION  PREDICTABILITY  ACCESSFDA’s Center for Drug Evaluation and ResearchJanuary 2021 Director’s Message Welcome to the FDA’s Center for Drug Evaluation and Research’s (CDER’s) annual report, […]

On This Page Date: July 23, 2024 Time: 1:00 PM – 2:00 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS WEBINAR (Hosted […]

On average, FDA determines that the vast majority of all expanded access requests may proceed. Sometimes called “compassionate use”, expanded access is a potential pathway for […]

For Post-Marketing Reports Drugs: FDA required that applicants electronically submit all ICSRs, ICSR attachments, and periodic safety reports. Refer to FDA Adverse Events Reporting System (FAERS) […]

On this page, you will find information about: What is expanded access? Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with a serious […]