FDA announces the fee rate for using a material threat medical countermeasure priority review voucher for fiscal year 2021.
Federal Register notice: FDA revokes the Emergency Use Authorizations issued to Autobio Diagnostics for the Anti-SARS-CoV2 Rapid Test because of poor ...
CDERs Office of Prescription Drug Promotion sends Nalpropion Pharmaceuticals a Warning Letter related to a sponsored link appearing on Googles search ...
Federal Register notice: FDA postpones until further notice a 10/7 meeting of its Medical Devices Advisory Committees Circulatory System Devices Panel...
In a rare approval reversal, FDA issues a proposal to withdraw Amag Pharmaceuticals Makena because a required postmarket study failed to verify clinic...
FDA issues Nephron Pharmaceuticals the first Warning Letter citing a prescription drug manufacturer for promoting its product for an unapproved use in...
A new CDER investigation of real-world evidence confirms that patients taking levothyroxine benefit equally from generic and brand-name drugs.
FDA Review posts the Federal Register notices for the week ending 10/2/2020.