Attorney Howard Dorfman says the CMS proposal to require companies to include the prescription drug wholesale acquisition price in DTC ads is ill-conc...
An FDA notice outlines NDA/BLA/ANDA user fee acceptance dates for submissions received during the partial government shutdown.
FDA clears a MediPines 510(k) for the MediPines Gas Exchange Monitor, which is intended for real-time pulmonary parameters and insights to support rap...
Researchers say most doctors surveys are concerned about FDA accelerated drug approvals and dont like eased restrictions on off-label marketing.
FDA releases its latest batch of Warning Letters that include Hangzhou Guoguang Touring Commodity Co. and University of Miami Reproductive and Fertili...
FDA issues a guidance extending the implementation date for electronic format submissions of Type 3 drug master files.
Morgan Lewis attorneys say FDA promises to write rules in the future to better align its human subject protection regulations with the new federal Com...
A year-long Bloomberg News investigation highlights concerns that FDA generic drug surveillance inspections have been dropping while the number of app...