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Federal Register

Purple Book Enhancements in First Phase

Federal Register notice: FDA announces the completion of the first phase of its enhanced Purple Book for biologics.

Medical Devices

Public Meeting on Device User Fee Reauthorization

FDA announces a 4/7 public meeting on reauthorizing the Medical Device User Fee Amendments for fiscal years 2023 through 2027.

Human Drugs

Hahn Updates FDA Actions on CBD

FDA commissioner Stephen Hahn updates agency education, data-gathering, and enforcement actions for CBD products.

Medical Devices

Coronavirus Test Goal Wont be Met: Pence

Vice president Mike Pence admits that the government will not meet its projected goal of delivering one million coronavirus tests throughout the U.S. ...

Human Drugs

Cancer Trial Inclusion Guidance

FDA publishes a draft guidance on including older adults in oncology clinical trials.

Medical Devices

FDA Bans Some Electrical Stimulation Devices

FDA publishes a final rule banning electrical stimulation devices for self-injurious or aggressive behavior.

Human Drugs

Deemed to be a License Questions, Answers

FDA publishes a question-and-answer guidance on the transition provision of the Biologics Price Competition and Innovation Act under which application...

Federal Register

Info Collection on GMPs for Medicated Feeds

Federal Register notice: FDA seeks comments on an information collection extension for medicated feed GMPs.

Federal Register

Regulatory Review Period for Kyowa Asthma Drug

Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Kyowa Hakko Kirins Fasenra (benralizumab).

Federal Register

Guide on Contacts Performance Criteria

Federal Register notice: FDA makes available a draft guidance entitled Soft (Hydrophilic) Daily Wear Contact Lenses Performance Criteria for Safety a...