FDA commissioner Robert Califf says those who call for the agency to approve drugs before their effectiveness is proven need to remember how much flex...
FDA issues a guidance giving the medical device industry recommendations for managing postmarket cybersecurity vulnerabilities in medical devices.
CDER sees a dramatic drop in innovative new drug approvals in 2016 just 22 approved which is half as many approved in 2015.
Janssen Biotech files a Supplemental BLA seeking approval of Stelara (ustekinumab) for treating adolescents (12 to 17 years of age) with moderate to s...
FDA approves updates to Pfizers Chantix (varenicline) labeling, including removal of a boxed warning on serious neuropsychiatric events.
Federal Register Notice: FDA makes available a guidance on Gifts to FDA: Evaluation and Acceptance.
Federal Register Notice: FDA seeks comments on an information collection related to Medical Devices; Pediatric Uses of Devices; Requirement for Submis...
Federal Register Notice: FDA makes available a guidance entitled Bioequivalence: Blood Level Bioequivalence Study.