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Need for Device Transparency Seen in Celect Case

[ Price : $8.95]

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PCCP Draft Guidance Stakeholder Recommendations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Two stakeholders request changes to an FDA draft guidance on predetermined change control plans for medical devices.

FDA Revokes EUAs on Covid Tests

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Federal Register notice: FDA revokes the Emergency Use Authorizations issued to Cue Health for the Cue Covid19 Test, and Cue Covid...

FDA Provides More Draft ANDA-Specific Guidances

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Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for generic drug sponso...

Fludarabine Phosphate Labeling Changes OKd

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FDA announces approved labeling changes for Sandoz fludarabine phosphate injection under the Oncology Center of Excellences Projec...

FDA Clears Ultromics EchoGo Amyloidosis Device

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FDA clears an Ultromics 510(k) for the EchoGo Amyloidosis for detecting cardiac amyloidosis.

Sage Ending Dalzanemdor Development

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Sage says it is ending dalzanemdor development in Huntingtons disease cognitive impairment following Phase 2 DIMENSION results tha...

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Fortesta Not Withdrawn Due to Safety/Efficacy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Federal Register notice: FDA determines that Endos Fortesta (testosterone) gel was not withdrawn due to safety or effectiveness re...