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...
FDA acting commissioner Janet Woodcock announces that CDER deputy director for operations Patrizia Cavazzoni has been appointed CDER director.