FDA publishes an International Council on Harmonization guidance on bioequivalence studies for immediate-release solid oral dosage forms.
FDA clears a Life Spine 510(k) for its ARx SAI (sacral alar iliac) Spinal Fixation System.
Two Axinn attorneys say FDA may be signaling more flexibility in considering novel Section viii carve-in statements in ANDAs.
Aquestive asks FDA not to approve any nasal sprays that do not submit food effect studies as part of their application.
FDA warns Amazon and Walmart they are introducing unapproved chemical peel products into interstate commerce.
Citing a lack of legal authority, FDA denies a Public Citizen 2019 petition asking it to join with the Drug Enforcement Administration to reschedule t...
FDA accepts for priority review a Novartis supplemental NDA for Scemblix (asciminib) for the drugs expanded use in treating newly diagnosed adult pati...
Federal Register notice: FDA sets the medical device user fee rates for fiscal year 2025.
