FDA makes available a guidance on Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Admi...
FDA Review posts the Federal Register notices for the week ending 9/29/2017.
FDA issues Intellipharmaceutics International a complete response letter on its Rexista (oxycodone hydrochloride) extended-release tablets for treatin...
Federal Register notice: FDA announces an 11/16 Antimicrobial Drugs Advisory Committee meeting that will review a Bayer NDA for ciprofloxacin inhalati...
Federal Register notice: FDA makes available a guidance entitled Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Mod...
FDA makes available a guidance on Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions.
Federal Register notice: FDA makes available a draft guidance entitled Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommenda...
Federal Register notice: FDA seeks comments or suggestions on issues relevant to the agencys newly established Opioid Policy Steering Committee.