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Federal Register notice: FDA releases a final guidance entitled Importation of Prescription Drugs Final Rule Questions and Answers...[ Price : $8.95]
FDA accepts for review a Phathom Pharmaceuticals NDA for vonoprazan as a treatment for adults in healing all grades of erosive eso...[ Price : $8.95]
FDA publishes a question-and-answer guidance for small entities on the provisions in the 2020 final rule on prescription drug impo...[ Price : $8.95]
Federal Register notice: FDA extends the comment period on a proposed rule on national standards for licensure for wholesale drug ...[ Price : $8.95]
Federal Register notice: FDA revokes the Emergency Use Authorization (EUA) issued to Clinical Research Sequencing Platform LLC at ...[ Price : $8.95]
FDA sends Nymox Pharmaceutical a Refusal to File letter for its NDA for fexapotide triflutate for treating benign prostatic hyperp...[ Price : $8.95]
FDA accepts for priority review a CSL Behring BLA for etranacogene dezaparvovec, an investigational gene therapy for treating adul...[ Price : $8.95]
The Informed Consent Action Network says FDA should revoke the EUA for Pfizers Covid vaccine in children ages 12-15 and not approv...