Public Citizen says FDA should adopt a policy that whenever it announces that a drug has been withdrawn for reasons of safety or effectiveness, it wil...
Braintree asks FDA to require particular specifications for any colonoscopy preparation tablet citing its Sutab as the reference-listed drug.
The 5th Circuit Court of Appeals says FTC acted correctly in issuing a cease-and-desist order to Impax preventing any future reverse payment settlemen...
FDA sends a Warning Letter to Maison Terre after conducting testing on its drug product labeled as Goldenseal Root Powder Organic and determining the ...
Attorney Andrew Goldfarb says Senate passage of a bill to codify in law FDAs active moiety definition for Waxman-Hatch five-year new active ingredient...
Federal Register notice: FDA reopens the comment period on an 11/16/2020 public meeting that requested public input on a potential revised approach fo...
Federal Register notice: FDA requests that public stakeholders notify it if they want to participate in periodic consultation meetings on reauthorizin...
Federal Register notice: FDA requests that public stakeholders notify it if they want to participate in periodic consultation meetings on reauthorizin...