Federal Register
Comments Sought on Safety Communication Surveys
Federal Register notice: FDA seeks comments on an information collection on FDA Safety Communication Readership Surveys.
Federal Register
Medical Imaging Drugs Panel Renewed for 2 Years
Federal Register notice: FDA announces the renewal of the Medical Imaging Drugs Advisory Committee.
Federal Register
Draft Guide on Drug Product Identifier Requirements
Federal Register notice: FDA announces the availability of a draft guidance on Product Identifier Requirements Under the Drug Supply Chain Security Ac...
Federal Register
Joint Panel to Review NDA for Pain Drug
Federal Register notice: FDA announces a 7/26 joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and R...
Human Drugs
HHS Inspector General Probe on Alexion Practices
The HHS Office of Inspector General discloses it has opened an investigation into Alexion Pharmaceuticals business practices.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Human Drugs
Latest Federal Register Notices
FDA Review posts Federal Register notices for the week ending 7/7/2017.
Biologics
BioMarin Files BLA for Phenylketonuria Therapy
BioMarin Pharmaceutical files a BLA for pegvaliase, a PEGylated recombinant phenylalanine ammonia lyase enzyme product, indicated for reducing blood p...
Federal Register
FDA Corrects Notice on NDA Information Collection
Federal Register correction notice: FDA corrects a 5/26 Federal Register notice about an information collection on Applications for Food and Drug Admi...
Federal Register
FDA Revokes Roche Emergency Use Authorization on Zika Test
Federal Register notice: FDA revokes an Emergency Use Authorization issued to Roche Molecular Systems for the LightMix Zika rRTPCR Test.
