McNeil Healthcare, LLC, Las Piedras, PR 483 issued 11/02/2010

This webinar will provide an in-depth look at the draft ICH M13B guideline titled “Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver” that was endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Assembly in March 2025.

Waltham, Mass. – Slade Gorton & Co., Inc, is recalling lot 3896 of Wellsley Farms Farm-Raised Atlantic Salmon sold in 2-lb bags at BJ’s Wholesale Club stores due to the potential for the product to be contaminated with Listeria monocytogenes.
Although healthy individuals may suffer only short-term s

Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs).

CDER has established a meeting program called the Emerging Drug Safety Technology Meeting (EDSTM) program. Learn more.

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

Unapproved New Drugs/Misbranded Botox