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, […]

March 2023: FDA issued a guidance for immediate implementation: Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices Under Section 524B of the FD&C Act. FDA […]

Summary Company Announcement Date: June 05, 2024 FDA Publish Date: June 05, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination Company Name: […]

On This Page Date: August 8, 2019 Time: 12:00 PM – 4:00 PM ET Co-sponsored by the:U.S. Food and Drug Administration (FDA) andthe Bladder Cancer Advocacy […]

Summary FDA has received reports of allergic-type reactions potentially related to sulfite-containing compounded drugs. FDA is alerting health care professionals, compounders and patients about the risk […]

CDER has established an Exclusivity Board to provide oversight and recommendations regarding exclusivity determinations made by the Center, with a primary focus on clarity and consistency […]

What We Do The Division of Applied Regulatory Science (DARS) moves new science into the FDA regulatory process and addresses emergent regulatory and public health questions. […]

Immediate Office (IO) Iilun C. Murphy, M.D., Director, Office of Generic Drugs (OGD) Darby Kozak, PhD, Deputy Director Kendra Stewart, R.Ph., Pharm.D., Deputy Director for Operations […]

The FDA is conducting a Model-Informed Drug Development (MIDD) Paired Meeting Program that will build on the success of the MIDD Paired Meeting Pilot by continuing […]