The pharmaceutical industry is expanding its use of artificial intelligence (AI) and other emerging technology across the drug product lifecycle. The Emerging Drug Safety Technology Meeting […]

CAPT. Chew: The misuse of antibiotics has contributed to one of the world’s most pressing public health problems today — antibiotic resistance. Hi, I’m Captain Catherine Chew […]

[embedded content] FDA Drug Info Rounds pharmacists discuss the application of the United States Pharmacopeia’s Monograph Naming Policy for Salt Drug Substances in Drug Products and […]

RSV Vaccines There are FDA-approved RSV vaccines for individuals 60 years of age and older, one for individuals 50 through 59 at increased risk of RSV […]

Español Respiratory syncytial virus or RSV is a highly contagious virus that causes mild, cold-like symptoms in most people. The virus is especially common in children, […]

Docket Number: FDA-2019-D-1469 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The guidance describes recommendations for method […]

Summary Company Announcement Date: February 01, 2024 FDA Publish Date: June 11, 2024 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Product is tainted […]

For Immediate Release: June 11, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

From a public health perspective, early identification of important adverse events is beneficial. For example, a relatively rare adverse event might be detected during expanded access […]