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Covid-19 and Annual Vaccinations is the New Normal: FDA

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Writing in a 5/2 online JAMA viewpoint, senior FDA officials prepare the agency and the public to accept that Covid-19 infections ...

Advisory Panel to Vote on Nuplazid Resubmission

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Federal Register notice: FDA announces a 6/17 Psychopharmacologic Drugs Advisory Committee meeting to vote on an Acadia Pharmaceut...

CGMP Deviations at Miami University Contract Lab

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FDA warns the Oxford, OH-based Miami University Department of Chemistry and Biochemistry contract testing laboratory about CGMP de...

Info Collection on Device Administrative Detention

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Federal Register notice: FDA sends to OMB an information collection extension entitled Administrative Detention and Banned Medical...

Senators Want Opioid Label Changes

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Sens. Hassan and Braun call on FDA commissioner Robert Califf to quickly lead a revision of opioid drug labeling.

FDA Lifts Hold on Pfizer Hemophilia A Gene Therapy

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FDA removes a clinical hold on Pfizers giroctocogene fitelparvovec (Hemophilia A gene therapy); the company plans to resume dosing...

FDA Proposes 2nd Section 518(b) Order for Philips

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FDA proposes issuing a second Section 518(b) order against Philips Respironics, this time to require the company to submit a plan ...

Confusion Over RWD and RWE: Perspective

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Two CDER executives discuss misconceptions that remain about the meaning and use of real-world data and real-world evidence.

Breakthrough for Limaca Endoscopic Ultrasound Biopsy

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FDA grants Limaca Medical a breakthrough device designation for its Precision-GI endoscopic ultrasound biopsy product.

Marqibo Accelerated Approval Withdrawn

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Federal Register notice: FDA withdraws the accelerated approval of Acrotech Biopharmas NDA for Marqibo (vincristine sulfate liposo...