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FDA Debars Brendon Gagne for 5 Years

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Federal Register notice: FDA issues an order debarring Brendon Gagne for five years from importing or offering for import any drug...

Qmiiz Not Withdrawn Due to Safety/Efficacy: FDA

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Federal Register notice: FDA determines that TerSera Therapeutics Qmiiz (meloxicam) orally disintegrating tablets, 7.5 mg and 15 m...

Panel to Select Flu Vaccine Strain Target

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Federal Register notice: FDA announces a 3/5 meeting of the advisory committee that will discuss strains to be included in next se...

Wake Up and Do Something: Califf on Misinformation

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FDA commissioner Robert Califf tells a George Washington University presentation on healthcare misinformation and disinformation t...

Chinese API Maker Hit with FDA-483

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FDA posts a six-item Form FDA-483 from a 9/2023 inspection at Sichuan Deebio Pharmaceutical Co. in Guanghan, Sichuan, China.

De Novo Pathway Challenges and Opportunities

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Three academic researchers say the FDA de novo medical device pathway has the potential to attract innovators who want to define n...

CDER Tests Communications for Clarity

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CDER Office of Communications social scientist Alexandria Smith says the Center tests some communications intended for consumers o...

Comments Sought on Drug Scheduling Recommendations

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Federal Register notice: FDA seeks comments concerning recommendations by the World Health Organization to impose international ma...

Philips BrightView CT System Recalled

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Philips North America recalls its BrightView computed tomography gamma camera system because of the risk of the detector unexpecte...

FDA Accepts Opdivo sNDA for New Indication

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FDA sets a 10/8 PDUFA action date for a Bristol Myers Squibb sNDA for Opdivo to treat some non-small cell lung cancers.