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Federal Register

Info Collection on Rx Drug Advsertising

Federal Register notice: FDA sends to OMB an information collection extension entitled Prescription Drug Advertising--21 CFR Part 202.

Federal Register

Medical Product Communications Info Collection

Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Product Communications That Are Consistent With the FDA...

Federal Register

Generic Animal Drug User Fee Rates

Federal Register notice: FDA announces the generic animal user fee rates and payment procedures for fiscal year 2022.

FDA General

3 More Former FDAers Join Greenleaf Health

Greenleaf Health adds former FDAers Julia Barrett, Chris Leptak, and Grace McNally to its regulatory consulting staff.

Human Drugs

FDA Not Meeting PDUFA Dates on 2 Pfizer NDAs

FDA says it will not meet the already-extended PDUFA action dates for Pfizer submissions for abrocitinib and Xeljanz.

FDA General

FDA Seeking New Patient Engagement Collaborative Members

FDA says it is soliciting applications for new Patient Engagement Collaborative members.

Human Drugs

Keytruda/Lenvima Combo Gains Full Approval

FDA grants full approval to the combination of Mercks Keytruda and Eisais Lenvima for treating certain patients with advanced endometrial carcinoma.

FDA General

Public Still Trusts FDA, CDC, Fauci: Survey

An Annenberg Public Policy Center poll shows that the degree of confidence in FDA respondents have varies with their primary source of media.

Medical Devices

Flexibility, Engagement are Covid Lessons for CDRH: Shuren

CDRH director Jeff Shuren says two important lessons learned during the Covid-19 emergency that CDRH envisions continuing long after the pandemic ends...

Biologics

Regen Centers Marketing Unapproved Cellular Products: FDA

An FDA Notice of Violation says The Regen Centers is marketing unapproved cellular products and exosomes.