Food and Drug Administration (FDA)

FDA may Issue Tougher EUA Standards

Amid worries in the American public that an unsafe vaccine could be approved by the US Food and Drug Administration just in time for the Nov. 3 election, the FDA reportedly will impose new, tougher, standards for an emergency authorization (EUA) of a coronavirus vaccine.

FDA Withdraws Hydroxychloroquine EUA

Contaminated Metformin Recalled in US

The Risk of Dependency in Pharma Supply Chains

FDA Says Pandemic Hasn’t Hit China’s Drug Exports

ECHA and FDA Waive Rules in Virus Crisis

FDA Relaxes Rules for Virus Diagnostic Tests

Virus Interrupts FDA Foreign Drug Inspections

FDA to Review Asbestos in Talc

Bayer’s Vitravki Faces Pricing Hurdles

Stephen Hahn Tapped to Head FDA

FDA Finds Asbestos in J&J Baby Powder

Advocacy Group Sues FDA Over Dopamine Warnings

FDA Approves US Merck-Pfizer Cancer Treatment

EMA Opens in Amsterdam

FDA Chief Scott Gottlieb Resigns

FDA Struggles with US Government Shutdown

FDA Chief Criticizes US Insulin Pricing

FDA Greenlights Bayer-Loxo’s Vitrakvi

FDA to Overhaul Medical Device Approval

FDA Approves Dompé’s Rare Eye Disease Drug

FDA Approves Teva’s Generic EpiPen

FDA Approves first Marijuana-based Drug

Industry 4.0 and the Pharmaceutical Industry

EU and US Extend Mutual Recognition

Lonza Expands in US, Moves Some Production

US Says BPA Safe as Europe Tightens Restrictions

FDA Confirms Xarelto Safety Profile

PMC Buys Isochem’s Pharma Business

FDA Approves new Two-drug HIV Treatment

Life Science Valley in the Heart of Europe

Dynavax Wins FDA Approval for Hepatitis B Vaccine

Roche Sues Pfizer to Block Herceptin Copy

FDA Approves First Digital Tracking Pill

The US Food and Drug Administration (FDA) has granted marketing approval for the first “digital” pill with a built-in sensor that can track whether patients have taken their medicine.

Pfizer Sells Stake in Chinese JV with Hisun