FDA General
Latest FDA Warning Letters
FDA releases its latest batch of Warning Letters that includes Casmara Cosmetics and Pacific Hospital Supply Co.
Human Drugs
MAPP on IND Clinical Holds
CDER issues a MAPP on procedures for issuing and overseeing clinical holds for INDs.
FDA General
Latest Federal Register Notices
FDA Review has posted the Federal Register notices for the week ending 2/16/2018.
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.
