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Drug Safety

Public Health Public Health Policy Vaccine Warnings Consumer Protection Mifepristone Review Opioid Regulations Tylenol Recommendations Recalls Acetaminophen Labeling Generic Drugs Labeling Changes Approval Processes Investigation Approval Process Research Policies Manufacturing Standards

6 ARTICLES

3w ago

FDA Delays Two Drugs in National Priority Voucher Program After Safety, Efficacy Flags

Internal documents show reviewers extended timelines after raising concerns over efficacy metrics, potential abuse risk, including a treatment-related death.

16 ARTICLES

2mo ago

FDA Reportedly Weighing Black Box Warning for COVID-19 Vaccines

9 ARTICLES

3mo ago

Trump Reposts Tylenol Pregnancy Warning, Urges Changes to Childhood Vaccine Schedule

10 ARTICLES

3mo ago

Kenvue Asks FDA to Reject Autism Warning on Tylenol in Pregnancy

7 ARTICLES

8mo ago

FDA Issues New Warning on Unapproved Tianeptine 'Gas Station Heroin' Products