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FDA issues a call for volunteers to pilot electronic delivery of premarket submissions during the Covid-19 pandemic.[ Price : $8.95]
FDA releases its latest batch of Warning Letters that include Essential Pharmaceutical and LEC Custom Products.[ Price : $8.95]
Senseonics Holdings files a PMA supplement seeking to extend the wearable life of the Eversense Continuous Glucose Monitoring Syst...[ Price : $8.95]
FDA announces the fee rate for using a material threat medical countermeasure priority review voucher for fiscal year 2021.[ Price : $8.95]
Federal Register notice: FDA revokes the Emergency Use Authorizations issued to Autobio Diagnostics for the Anti-SARS-CoV2 Rapid T...[ Price : $8.95]
CDERs Office of Prescription Drug Promotion sends Nalpropion Pharmaceuticals a Warning Letter related to a sponsored link appearin...[ Price : $8.95]
Federal Register notice: FDA postpones until further notice a 10/7 meeting of its Medical Devices Advisory Committees Circulatory ...[ Price : $8.95]
In a rare approval reversal, FDA issues a proposal to withdraw Amag Pharmaceuticals Makena because a required postmarket study fai...