CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections

The Food and Drug Administration is advising consumers not to purchase or use X3 500K GOLD EDITION, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

FDA/CDER SBIA Chronicles, the bi-monthly newsletter of the CDER Small Business and Industry Assistance team, provides industry with useful information to assist in all aspects of drug marketing and regulation

Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Public Engagement Staff draft summaries for FDA-requested sessions and the patient community requester drafts summaries for Patient-led sessions.

Sanger, CA – February 13, 2026 – IF Copack LLC d.b.a. Initiative Foods (“Initiative Foods”) is recalling one lot of the “Tippy Toes” brand Apple Pear Banana Fruit puree (“Product”) due to elevated levels of patulin. Patulin is a naturally occurring substance (called a mycotoxin) which is produced b

Unapproved New Drugs/Misbranded Botox

CDER Guidance Agenda