On November 26, 2018, the FDA announced its intent "to modernize the FDA's 510(k) clearance pathway" by encouraging manufacturers to rely on newer (that is, 10 years old or less) medical devices ...

The U.S. Food & Drug Administration ("FDA") announced in an early morning press release on November 7, 2017, that it is withdrawing the draft Guidance for Industry #230, "Compounding Animal Drugs from Bulk Drug Substances."

On September 26, 2017, FDA Commissioner Scott Gottlieb, M.D. released a statement about FDA's ramped up regulatory initiatives for drug compounders.