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Burdensome Device Assessment Guidance: Post

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Two medical device experts use a Hyman, Phelps & McNamara post to urge FDA to provide additional guidance to ease what they see as...

Johns Hopkins Surgeon Eyed for FDA Top Job

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News outlets report that Johns Hopkins surgeon Marty Makary is likely to be nominated by president-elect Donald Trump as the next ...

Need for Device Transparency Seen in Celect Case

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Academic medical center authors writing in the Annals of Internal Medicine say litigation involving the Cook Celect IVC filter dem...

PCCP Draft Guidance Stakeholder Recommendations

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Two stakeholders request changes to an FDA draft guidance on predetermined change control plans for medical devices.

Draeger Atlan Recall is Class 1

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FDA says the Draeger recall correction of its Atlan A350 and A350XL anesthesia workstations is Class 1.

Smiths Recalls Infusion Pump Battery Packs

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Smiths Medical recalls (Class 1) its CADD-Solis Li-ion Rechargeable Battery Packs to update instructions for use due to a potentia...

Fortesta Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Endos Fortesta (testosterone) gel was not withdrawn due to safety or effectiveness re...

Third-Party Review Guidance

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FDA publishes a guidance with information on third-party review of 510(k)s and emergency use authorizations.

New DTC Major Statement Standards Become Effective

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New FDA advertising standards require drug marketers to ensure their direct-to-consumer advertisements major statement is presente...

Preserve Covid-19 Vaccine Records: Senator

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Republican Sen. Ron Johnson orders FDA, HHS, and CDC to preserve all records relating to Covid-19 vaccines, saying they will be su...