FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Human Drugs
FDA Panel Votes Down Pacira sNDA for Pain Blocker
FDAs Anesthetic and Analgesic Drug Products Advisory Committee votes 6 to 4 to not recommend approval of a Pacira Pharmaceuticals supplemental NDA for...
Federal Register
Public Meeting on Pediatric Device Development
Federal Register notice: FDA announces an 8/13-14 public meeting entitled Pediatric Medical Device Development.
Federal Register
Guide on How to Prepare Combination Product Designation Request
Federal Register notice: FDA makes available a guidance entitled How to Prepare a Pre-Request for Designation (Pre-RFD).
Human Drugs
FDA Approves AstraZenecas Imfinzi in Lung Cancer
FDA approves AstraZenecas Imfinzi (durvalumab) for treating patients with Stage III non-small cell lung cancer whose tumors are not able to be surgica...
Human Drugs
FDA Mulls European Drug Supplies for Generic Testing: Gottlieb
As a means to help bring down rising drug costs, FDA commissioner Scott Gottlieb says the agency is exploring how to allow generic drug firm to acquir...
Medical Devices
NEJM Perspective Breaks Down Real World Evidence for Devices
Two medical device researchers outline benefits and pitfalls of FDA relying on real world evidence in their regulatory decision making.
Federal Register
Lotensin HCT Not Withdrawn Due to Safety/Efficacy
Federal Register notice: FDA determines that U.S. Pharmaceutical Holdings Lotensin HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5...
Federal Register
Draft Guide on eSubmission Data for BIMO Inspection Prep
Federal Register notice: FDA makes available a draft guidance entitled Standardized Format for Electronic Submission of NDA and BLA Content for the Pl...
Federal Register
Panel to Review Akcea Therapeutics NDA in May
Federal Register notice: FDA announces a 5/10 Endocrinologic and Metabolic Drugs Advisory Committee meeting to review Akcea Therapeutics NDA.
