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Regulatory Review Period for TherOx Downstream System

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for TherOxs PMA for the TherOx ...

CGMP Violations at Green Wave Analytical

[ Price : $8.95]

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

Priority Review for Sanofis Efanesoctocog Alfa

[ Price : $8.95]

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

Priority Review Voucher Used on Lillys Mounjaro

[ Price : $8.95]

Federal Register notice: FDA announces that Eli Lilly used a priority review voucher for the approval of its NDA for Mounjaro (tir...

EUA for Novavax Covid-19 Vaccine

[ Price : $8.95]

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

Device Cybersecurity Firm Hires Former FDA Reviewer

[ Price : $8.95]

Medical device cybersecurity consulting firm MedCrypt hires former CDRH Diabetes Diagnostics Device Branch lead reviewer Naomi Sch...

FDA Clears BrainsWay Device for Depression

[ Price : $8.95]

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

Florida Sues FDA Over Drug Importation Plan

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

Multiple Violations at Elite One Source

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FDA warns Missoula, MT-based Elite One Source Nutritional Services about dietary supplement CGMP and misbranding violations.

Lessons Learned from PPI Case Studies

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The Medical Device Information Consortium publishes information from a working group looking at the benefits of and approaches to ...