Health ❯Healthcare ❯Regulatory Agencies

FDA

Vaccine Approval Process Product Recalls Drug Warnings Recalls Drug Approval Process Emergency Use Authorization Drug Approval Processes Drug Evaluation Drug Safety Reviews Drug Rejection

FDA Publishes Over 200 Complete Response Letters for 2020–24 Drug Applications

The release aims to demystify the FDA’s review process through transparent feedback redacted for confidentiality.

Stories older than 24h

FDA Restricts Moderna and Novavax COVID-19 Vaccines to Seniors and Vulnerable Groups

FDA Expands Myocarditis and Pericarditis Warnings on mRNA COVID-19 Vaccines

Medtech Products Recalls Children's Honey Cough Syrup Over Bacterial Contamination

FDA Introduces Elsa AI to Fast-Track Drug and Device Approvals

US Stops Recommending COVID-19 Shots for Healthy Kids and Pregnant Women

FDA Audit Triggers Nationwide Recall of Over 75,000 Eye Care Products

FDA Recalls Acne Products Over Benzene Contamination Concerns

Systane Eye Drops Recalled Over Potential Fungal Contamination

Systane Eye Drops Recalled Nationwide Over Fungal Contamination Risk

FDA Recalls Over 233,000 Bottles of Antidepressant Duloxetine for Cancer-Causing Impurity

Clonazepam Recalled Nationwide Over Potentially Life-Threatening Labeling Error

FDA Faces Uncertain Future with Trump's Return and RFK Jr.'s Influence

Novo Nordisk Urges FDA to Ban Compounded Versions of Ozempic and Wegovy

Critical IV Fluid Shortage Disrupts US Hospitals

FDA Mandates Breast Density Information in Mammogram Reports

New Studies Confirm Safety of Semaglutide for Mental Health

New Study Links Ozempic to Increased Risk of Suicidal Thoughts

New Study Fuels Debate on Semaglutide's Mental Health Risks

FDA Declines MDMA for PTSD Treatment, Requests Further Trials