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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...

CDER Deputy Throckmorton Retiring in January

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CDER deputy director for regulatory programs Doug Throckmorton announces his retirement after 27 years at the agency.

Toms of Maine CGMP Issues

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FDA warns the Colgate-Palmolive Toms of Maine unit about CGMP violations in its manufacturing of finished drugs.

Cell/Gene Therapy Product Frequent Questions

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Federal Register notice: FDA makes available a draft guidance entitled Frequently Asked Questions Developing Potential Cellular a...

Jesduvroq Not Withdrawn Over Safety/Efficacy

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Federal Register notice: FDA determines that GlaxoSmithKlines Jesduvroq (daprodustat) tablets were not withdrawn due to safety or ...

Advisors Asked About Generative AI Regulation

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FDA asks members of its Digital Health Advisory Committee to spend two days discussing agency questions about its role in regulati...

Astellas Gets Complete Response on Izervay sNDA

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FDA sends Astellas Pharma a complete response letter on a supplemental NDA for Izervay (avacincaptad pegol intravitreal solution) ...

Stakeholder Comments on Oncology Trial Guidance

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Three stakeholders raise concerns about an FDA draft guidance on considerations for generating clinical evidence from multiregiona...