Docket Number: FDA-2023-D-3031 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration (FDA […]

CDER researchers are developing methods based on deep learning, a kind of artificial intelligence (AI), to capture patient experience of medical products in a way that […]

On this page Over-the-Counter Drug Research Evaluation of Sunscreen Active Ingredients DARS has conducted two randomized clinical trials which demonstrated systemic exposure of multiple commonly used […]

Drugs and the technologies used to deliver them evolve rapidly, and methods to evaluate them must be continually adapted to ensure the safety and efficacy of […]

Summary Company Announcement Date: January 09, 2023 FDA Publish Date: January 09, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Product discoloration Company Name: […]

Summary Company Announcement Date: September 29, 2023 FDA Publish Date: October 03, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Presence of Oxycodone […]

On September 10, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) granules and capsules for pediatric patients 1 year of age and […]

Docket Number: FDA-2025-D-0610 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]