Baxter Oncology GmbH – 09/26/2025

The Genetic Metabolic Diseases Advisory Committee (GeMDAC) advises the Commissioner of Food and Drugs or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs and biologic products for human use and as required.

The Food and Drug Administration is advising consumers not to purchase or use RIGIDRX, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

eCTD Submission Standards

CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.

Goodlettsville, Tennessee – August 11, 2025 –Dollar General Corporation is recalling three (3) lots of its eight (8) ounce Clover Valley® Instant Coffee due to the potential presence of glass.

Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint