FDA issues a call for volunteers to pilot electronic delivery of premarket submissions during the Covid-19 pandemic.
FDA releases its latest batch of Warning Letters that include Essential Pharmaceutical and LEC Custom Products.
Attorney Karin Moore says the 3rd Circuit Court of Appeals has joined the 7th Circuit and two judges in the 9th Circuit in determining that FTC does n...
Senseonics Holdings files a PMA supplement seeking to extend the wearable life of the Eversense Continuous Glucose Monitoring System from 90 to 180 da...
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...