FDA says research indicates that collaborative good clinical practice inspections by FDA and the European Medicines Agency provide comparable results.
Two former FDA attorneys say proposed BLOCKING legislation will not have its intended effect of accelerating generic drug entry into the marketplace.
Federal Register notice: FDA releases a final guidance entitled Importation of Prescription Drugs Final Rule Questions and Answers.
FDA accepts for review a Phathom Pharmaceuticals NDA for vonoprazan as a treatment for adults in healing all grades of erosive esophagitis and relief ...
FDA publishes a question-and-answer guidance for small entities on the provisions in the 2020 final rule on prescription drug importation.
Federal Register notice: FDA extends the comment period on a proposed rule on national standards for licensure for wholesale drug distributors that pu...
Federal Register notice: FDA revokes the Emergency Use Authorization (EUA) issued to Clinical Research Sequencing Platform LLC at the Broad Institute ...
FDA sends Nymox Pharmaceutical a Refusal to File letter for its NDA for fexapotide triflutate for treating benign prostatic hyperplasia, requesting lo...