On March 28, 2025, the Food and Drug Administration expanded the indication for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation) to include adults with […]

[03/28/2025] FDA has identified significant data integrity and study conduct concerns with bioequivalence studies conducted by Raptim Research Pvt. Ltd., a contract research organization (CRO) based […]

On This Page Date: May 5, 2025 Time: 8:00 a.m. – 5:00 p.m. ET What is an advisory committee? Advisory committees provide independent expert advice to […]

On This Page Location Details The Universities at Shady Grove; Building II, 9630 Gudelsky Drive, Rockville, MD Event Details The In Vitro Permeation Test (IVPT) is […]

The Biologics Price Competition and Innovation Act (BPCIA), enacted March 23, 2010, was designed to create a regulatory pathway for the approval of biosimilars. It provides […]

FDA publishes a variety of lists and reports on generic drug application activities for public awareness, including: Content current as of: 03/26/2025 Regulated Product(s)

On March 26, 2025, the Food and Drug Administration approved cabozantinib (Cabometyx, Exelixis, Inc.) for adult and pediatric patients 12 years of age and older with […]

  Minimum Inhibitory Concentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S I R S I R Enterobacteralesa ≤ 16 32 ≥ 64 ≥ 12 8-11 ≤ […]

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-01-01 Product: Drugs Recipient: Americo F. Padilla, M.D. 8955 Southwest 87th Court, Suite 110Miami, FL […]