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BLOCKING Act Would Hurt Generic Drug Access: Attorneys

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Two former FDA attorneys say proposed BLOCKING legislation will not have its intended effect of accelerating generic drug entry in...

Q&A Guide on Importing Canadian Drugs

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Federal Register notice: FDA releases a final guidance entitled Importation of Prescription Drugs Final Rule Questions and Answers...

Phathom NDA for Erosive Esophagitis NDA Accepted

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FDA accepts for review a Phathom Pharmaceuticals NDA for vonoprazan as a treatment for adults in healing all grades of erosive eso...

Drug Importation Small Entity Q&A

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FDA publishes a question-and-answer guidance for small entities on the provisions in the 2020 final rule on prescription drug impo...

Comments Extended on Drug Distributor Rule

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Federal Register notice: FDA extends the comment period on a proposed rule on national standards for licensure for wholesale drug ...

FDA Revokes EUA for Covid Test

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Federal Register notice: FDA revokes the Emergency Use Authorization (EUA) issued to Clinical Research Sequencing Platform LLC at ...

FDA Refuses to File Nymox Pharma NDA

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FDA sends Nymox Pharmaceutical a Refusal to File letter for its NDA for fexapotide triflutate for treating benign prostatic hyperp...

CSL Behring BLA for Hemophilia B Gene Therapy

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FDA accepts for priority review a CSL Behring BLA for etranacogene dezaparvovec, an investigational gene therapy for treating adul...

Revoke Childrens Covid Vaccine EUA: ICAN

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The Informed Consent Action Network says FDA should revoke the EUA for Pfizers Covid vaccine in children ages 12-15 and not approv...

Santhigram Kerala Selling Unapproved Drugs: FDA

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FDA cautions Santhigram Kerala Ayurvedic Co. of U.S. that it is marketing unapproved new drugs, including two it says will treat C...