Pre-Conference Quality Essentials Pre-Conference Quality Essentials time: 2:31:13 FDA presentations followed by questions and discussion that will explore fundamental concepts in quality, including Quality Unit formation […]

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, […]

Checking a pharmacy’s license through your state board of pharmacy is an important step in knowing whether you are using a safe online pharmacy. Click on […]

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 […]