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FDA General

FDA Needs More Evidence for Good Decisions: Califf

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...

Medical Devices

Medical Device Cybersecurity Management Guidance

FDA issues a guidance giving the medical device industry recommendations for managing postmarket cybersecurity vulnerabilities in medical devices.

Human Drugs

Half as Many New Drugs Approved in 2016 as in 2015

CDER sees a dramatic drop in innovative new drug approvals in 2016 just 22 approved which is half as many approved in 2015.

Biologics

Janssen Biotech sBLA for Stelara in Adolescents

Janssen Biotech files a Supplemental BLA seeking approval of Stelara (ustekinumab) for treating adolescents (12 to 17 years of age) with moderate to s...

Human Drugs

FDA Allows Pfizer to Remove Boxed Warning From Chantix

FDA approves updates to Pfizers Chantix (varenicline) labeling, including removal of a boxed warning on serious neuropsychiatric events.

Federal Register

Guidance on FDA accepting Gifts on Behalf of U.S.

Federal Register Notice: FDA makes available a guidance on Gifts to FDA: Evaluation and Acceptance.

Federal Register

Comments Sought on Device Pediatric Info Collection

Federal Register Notice: FDA seeks comments on an information collection related to Medical Devices; Pediatric Uses of Devices; Requirement for Submis...

Federal Register

Guidance on CVM Blood Level Bioequivalence Studies

Federal Register Notice: FDA makes available a guidance entitled Bioequivalence: Blood Level Bioequivalence Study.

Federal Register

Guidance on FDA accepting Gifts on Behalf of U.S.

Federal Register Notice: FDA makes available a guidance on Gifts to FDA: Evaluation and Acceptance.

Human Drugs

Agios Pharma Stops Drug Development After FDA Hold

Agios Pharmaceuticals pulls the plug on its development program involving its second pyruvate kinase-R activator, AG-519, and withdraws its investigat...