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Guide on Monkeypox Diagnostic Tests

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Policy for Monkeypox Tests To Address the Public Health Eme...

Proposed OTC Contraceptive Heads to Panel

[ Price : $8.95]

Federal Register notice: FDA announces an 11/18 joint advisory committee meeting to discuss a Laboratoire HRA Pharma supplemental ...

Streamlined GMP Requirements for Combo Products

[ Price : $8.95]

Federal Register notice: FDA finalizes a list of alternative or streamlined mechanisms for complying with GMP requirements for com...

Guidance for Computer Software Assurance for Devices

[ Price : $8.95]

FDA publishes a draft guidance entitled Computer Software Assurance for Production and Quality System Software that the agency say...

FDA Approves BMS Plaque Psoriasis Drug

[ Price : $8.95]

FDA approves a Bristol Myers Squibb NDA for plaque psoriasis drug Sotyktu (deucravacitinib), a first-in-class, oral, selective, al...

Biomarin Reports Leukemia in Patient on Gene Therapy

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BioMarin Pharmaceutical tells FDA a patient participating in the companys hemophilia A Phase 3 gene therapy trial of valoctocogene...

FDA Taps PATHs Kaslow as Vaccine Chief

[ Price : $8.95]

FDA selects non-profit PATHs chief scientific officer David Kaslow as CBER Office of Vaccines Research and Review director.

Statement of Identity and Strength Labeling Draft Guide

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Federal Register notice: FDA makes available a draft guidance entitled Statement of Identity and Strength Content and Format of L...

Teva Rebuts GSK Argument in Skinny Label Case

[ Price : $8.95]

Teva urges the U.S. Supreme Court to dismiss a GlaxoSmithKline argument that the high court should not hear Tevas appeal of a skin...

Boston Imaging V7 Ultrasound Cleared

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FDA clears a Boston Imaging 510(k) for its V7, an ultrasound system said to enhance image clarity.