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Implementing ICH Q12 Postapproval Changes

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Federal Register notice: FDA makes available a draft guidance to help implement the ICH Q12: document on postapproval changes.

Overjet Dental Assist AI Cleared

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FDA clears an Overjet 510(k) for its Overjet Dental Assist artificial intelligence product that performs measurement for treating ...

Brukinsa Priority NDA for Marginal Zone Lymphoma

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FDA accepts for priority review a BeiGene supplemental NDA for Brukinsa (zanubrutinib) for treating adult patients with marginal z...

More ANDA-specific Bioequivalence Guidances

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Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that provide bioequival...

Guide on Device MRI Testing and Labeling

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Federal Register notice: FDA makes available a final guidance on Testing and labeling medical devices as MRI-safe.

CDRH Research on Implant Adverse Events

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CDRH announces research efforts it will undertake to address scientific knowledge gaps in host responses to an implanted metal dev...

Janssen Lung Cancer Therapy Approved

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FDA approves a Janssen Pharmaceutical NDA for Rybrevant (amivantamab-vmjw) for treating adult patients with non-small cell lung ca...

Boston Scientific Recalls Venous Stent Systems

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Boston Scientific recalls its VICI SDS and RDS Venous Stent Systems after receiving reports indicating the devices may migrate or ...

Real-World Data/Evidence Grew Under Covid: FDA

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FDA officials describe how the Covid-19 pandemic led to quicker and greater acceptance of real-world data/evidence.

Revised FDA Guidance on Covariate Adjustment in Trials

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FDA issues a revised draft guidance on covariate adjustment in some drug and biologic clinical trials.