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Federal Register

User Fee Rate for Medical Countermeasure App

FDA announces the fee rate for using a material threat medical countermeasure priority review voucher for fiscal year 2021.

Federal Register

EUA Revoked on Autobio Diagnostics Covid Test

Federal Register notice: FDA revokes the Emergency Use Authorizations issued to Autobio Diagnostics for the Anti-SARS-CoV2 Rapid Test because of poor ...

Marketing

OPDP Hits Contrave Sponsored Link

CDERs Office of Prescription Drug Promotion sends Nalpropion Pharmaceuticals a Warning Letter related to a sponsored link appearing on Googles search ...

Federal Register

Medical Devices Advisory Committee Postponement

Federal Register notice: FDA postpones until further notice a 10/7 meeting of its Medical Devices Advisory Committees Circulatory System Devices Panel...

Human Drugs

FDA Seeks Makena Drug Withdrawal

In a rare approval reversal, FDA issues a proposal to withdraw Amag Pharmaceuticals Makena because a required postmarket study failed to verify clinic...

Marketing

Nephron Pharma Warned on Email Unapproved Use

FDA issues Nephron Pharmaceuticals the first Warning Letter citing a prescription drug manufacturer for promoting its product for an unapproved use in...

Human Drugs

CDER Sees Generic Equality in a Levothyroxine Study

A new CDER investigation of real-world evidence confirms that patients taking levothyroxine benefit equally from generic and brand-name drugs.

FDA General

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 10/2/2020.

Federal Register

Guide on Opioid Use Disorder Clinical Endpoints

Federal Register notice: FDA makes available a final guidance entitled Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Tre...

Federal Register

Orphan Drugs Info Collection Revision

Federal Register notice: FDA seeks comments on an information collection revision for Orphan Drugs; 21 CFR Part 316.