Please see the list below for available calendar year reports on New Drug Application (NDA) and Biologic License Application (BLA) approvals. Reports Resources Content current as of: 09/29/2017 Regulated […]

Drugs@FDAIncludes information about drugs approved for human use in the United States: Drug information, Regulatory history, Most recent FDA-approved Prescribing Information and patient labeling, and Reviews […]

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

Pharmacists, prescribers, and other health care providers are required to provide patients or their caregiver with FDA-approved Medication Guides in certain circumstances to help ensure their […]

On This Page Date: December 14, 2023 Time: 12:00 PM – 5:00 PM ET On December 14th, 2023, the FDA in collaboration with the Duke-Robert J. […]

On This Page As will be announced in the Federal Register notice on June 11, 2024, CDER has established a meeting program called the Emerging Drug […]

Introducing the Emerging Drug Safety Technology Program (EDSTP) The EDSTP is specifically focused on the use of artificial intelligence (AI) and other emerging technologies in pharmacovigilance […]

For Immediate Release: June 07, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

  Minimum InhibitoryConcentrations (mcg/mL) Disk Diffusion(zone diameters in mm) Pathogen S I R S I R Acinetobacter-baumannii calcoaceticus complex M100 standard is recognized S = Susceptible; […]