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Priority Review Voucher Awarded to Y-mAbs Therapeutics

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Federal Register notice: FDA announces that Y-mAbs Therapeutics was awarded a priority review voucher related to the approval of D...

FDA Testing Annotated Electrocardiogram eSubmissions

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FDA tests its capability to receive annotated electrocardiogram waveform data in electronic format under the Health Level Seven (H...

FDA Faulted on Inspection Alternatives

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Former FDA Office of Compliance and Biologics Quality deputy director Mark I. Schwartz criticizes FDA for its slow response to the...

Feds Sue Firm Selling Unapproved Drugs

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The Justice Department files a civil complaint to stop AMARC Enterprises from distributing unapproved and misbranded drugs and adu...

Alert on Face Masks Containing Metal During MRI

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FDA issues a safety alert to warn patients and health care providers about patient injuries from wearing face masks that contain m...

Pilot on Innovative Drug Development Tools

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FDA details the launch of a new pilot program to provide a pathway for novel drug development tools to be used in regulatory appli...

Protective Barrier Enclosures, Infusion Pump EUAs Revoked

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Federal Register notice: FDA announces the revocations of Emergency Use Authorizations issued to manufacturers of certain protecti...

FDA Moves Ahead on DTC Endorsements Research

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CDERs Office of Prescription Drug Promotion seeks approval to expanding on previous direct-to-consumer advertising research involv...

Device User Fee Activities Hurt by Covid Demands: Shuren

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CDRH director Jeff Shuren says the Center has seen its work load grow substantially under the Covid-19 pandemic, and its having a ...

Covid Guidance on Clinical Trials Revised

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FDA adds product disposal content to a question-and-answer appendix in its guidance titled Conduct of Clinical Trials of Medical P...