Apotex Inc. – 714137 – 10/31/2025
CGMP/Finished Pharmaceuticals/Adulterated
Liebel-Flarsheim Company LLC – 711508 – 10/17/2025
CGMP/Finished Pharmaceuticals/Adulterated
Kath Khemicals LLC – 711699 – 09/22/2025
CGMP/Finished Pharmaceuticals/Adulterated
Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine – 12/16/2025
This one-day hybrid (virtual and in person) workshop will initiate a discussion on expanding epinephrine accessibility and use, including in…
FDA approves 1st drug for thymidine kinase 2 deficiency, a very rare mitochondrial disease
FDA approves 1st drug for thymidine kinase 2 deficiency, a very rare mitochondrial disease
Quit Kit, LLC – Online Advisory Letter
Quit Kit, LLC – Online Advisory Letter
BsUFA IV: Fiscal Years 2028-2032
On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022.
Issue Information
No abstract is available for this article.
Ingestible Fluoride Drug Products
FDA recommends that ingestible fluoride drug products – typically available as tablets and drops – should be limited to children…