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Human Drugs

CGMP Violations at Green Wave Analytical

FDA warns San Diego, CA-based Green Wave Analytical about CGMP and other violations in its work as a contract testing laboratory for drug products and...

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Human Drugs

Priority Review for Sanofis Efanesoctocog Alfa

FDA grants priority review for a Sanofi BLA for efanesoctocog alfa to treat hemophilia A.

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Federal Register

Priority Review Voucher Used on Lillys Mounjaro

Federal Register notice: FDA announces that Eli Lilly used a priority review voucher for the approval of its NDA for Mounjaro (tirzepatide), a once-we...

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Federal Register

EUA for Novavax Covid-19 Vaccine

Federal Register notice: FDA announces an Emergency Use Authorization issued 7/13 to Novavax, Inc. for its Novavax Covid19 Vaccine.

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Medical Devices

Device Cybersecurity Firm Hires Former FDA Reviewer

Medical device cybersecurity consulting firm MedCrypt hires former CDRH Diabetes Diagnostics Device Branch lead reviewer Naomi Schwartz as the firms n...

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Medical Devices

FDA Clears BrainsWay Device for Depression

FDA clears a BrainsWay 510(k) for its Deep TMS H7 Coil for use in treating adults suffering from major depressive disorder and depression.

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Human Drugs

Florida Sues FDA Over Drug Importation Plan

The state of Florida files a lawsuit against FDA for failing to timely respond to a state-sought Freedom of Information Act request seeking informatio...

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Federal Register

2 Draft Guides on Drug Analytical Procedures

Federal Register notice: FDA posts two draft guidances entitled Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development....

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Federal Register

bluebird bio Wins Priority Voucher

Federal Register notice: FDA issues bluebird bio a priority review voucher for obtaining approval of Zynteglo (betibeglogene autotemcel), indicated fo...

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Human Drugs

BMS, Janssen Moving Stroke Drug to Phase 3

After reporting Phase 2 data, Bristol Myers Squibb and Janssen Pharmaceuticals say they are planning to begin a Phase 3 trial of their investigational...