Recall Alert: BALT USA Removes MEGA Ballast Distal Access Platform

It has become increasingly clear that new approach methodologies (NAMs)—when combined with knowledge of the pathway, results of pharmacology studies, and other relevant data—may offer ways to reduce animal testing.

Resources and information for requestors interested in CDER’s Clinical Outcome Assessments (COA) Qualification Program.

This update contains the Letter of Intent Template for the COA Qualification Program, as described under section 507 of the Federal Food, Drug, and Cosmetic Act.

Salinas, Calif., August 26, 2025 – In response to a recall initiated by Latitude 36 Foods, LLC., Taylor Fresh Foods is voluntarily recalling the Taylor Farms Honey Balsamic Salad Kit 6/8.3oz. because it may contain undeclared sesame and soy allergens. People who have an allergy or severe sensitivity

On September 18 and 19, 2025, the U.S. Food and Drug Administration (FDA) is hosting a virtual public workshop to discuss methodological challenges related to patient experience data encountered, including the submission and evaluation of patient experience data in the context of the benefit-risk assessment and product labeling, as well as other ar

On September 9, 2025, the Food and Drug Administration approved gemcitabine intravesical system (Inlexzo, Janssen Biotech, Inc.) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors

GE HealthCare issues updated use instructions for certain Carestation 600 and 700 series Anesthesia Systems