FDA warns Colombias Proquimes SA Productos Quimicos Especializados about CGMP deviations in its production of APIs.
FDAs Global Engagements Team reviews 10 years of successes under the U.S.-Canada Regulatory Cooperation Council.
Public Citizen says FDA should adopt a policy that whenever it announces that a drug has been withdrawn for reasons of safety or effectiveness, it wil...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...