[ Price : $8.95]
FDA publishes an International Council on Harmonization guidance on bioequivalence studies for immediate-release solid oral dosage...[ Price : $8.95]
FDA clears a Life Spine 510(k) for its ARx SAI (sacral alar iliac) Spinal Fixation System.[ Price : $8.95]
Two Axinn attorneys say FDA may be signaling more flexibility in considering novel Section viii carve-in statements in ANDAs.[ Price : $8.95]
Aquestive asks FDA not to approve any nasal sprays that do not submit food effect studies as part of their application.[ Price : $8.95]
FDA warns Amazon and Walmart they are introducing unapproved chemical peel products into interstate commerce.[ Price : $8.95]
Citing a lack of legal authority, FDA denies a Public Citizen 2019 petition asking it to join with the Drug Enforcement Administra...[ Price : $8.95]
FDA accepts for priority review a Novartis supplemental NDA for Scemblix (asciminib) for the drugs expanded use in treating newly ...[ Price : $8.95]
Federal Register notice: FDA sets the medical device user fee rates for fiscal year 2025.