Human Drugs
CDER Officials Plug Master Protocols for Precision Medicine
CDER officials advocate for more use of master protocols for precision medicine trials to evaluate targeted therapies.
Federal Register
FDA Files Annual Reports on Closed Panel Meetings
Federal Register notice: FDA files with the Library of Congress annual reports of certain FDA advisory committees that held closed meetings during fis...
Federal Register
Approved Information Collection Listing
Federal Register notice: FDA publishes a list of information collections that have been approved by the Office of Management and Budget.
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Federal Register notice: FDA announces the availability of a draft guidance on Product Identifier Requirements Under the Drug Supply Chain Security Ac...
Human Drugs
Latest Federal Register Notices
FDA Review posts Federal Register notices for the week ending 7/7/2017.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
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...
