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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 ...

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 ...

FDA Introduces Overdose Prevention Framework

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FDA commissioner Robert Califf says the agency has launched a drug overdose prevention framework with four overarching priorities.

FDA Lifts Hold on Curis Leukemia Study

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FDA lifts a partial clinical hold on Curis TakeAim Leukemia study that is intended to evaluate emavusertib in a monotherapy phase ...

Hamilton Medical Ventilator Recalled

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Hamilton Medical recalls its Hamilton-C6 Intensive Care Ventilator after customer complaints were received about a hardware issue ...

Outlook Resubmits ONS-5010 BLA

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Outlook Therapeutics resubmits to FDA a BLA for its ONS-5010 to treat wet age-related macular degeneration.

CGMP Violations at Green Wave Analytical

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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

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

Priority Review Voucher Used on Lillys Mounjaro

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