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Tazverik Approved for Follicular Lymphoma

[ Price : $8.95]

FDA grants Epizyme accelerated approval for Tazverik (tazemetostat), an EZH2 inhibitor for certain adult patients with relapsed or...

Guide on Patient-Focused Drug Development

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Federal Register notice: FDA makes available a final guidance on Patient-Focused Drug Development: Collecting Comprehensive and Re...

Covid Trial Statistical Considerations Guidance

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FDA issues an immediately-in-effect guidance on statistical considerations for proposed changes to clinical trials that may affect...

Establish Regulatory Pathway for CBD Supplements: Petition

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The Council for Responsible Nutrition asks FDA to lay out a regulatory pathway for approval of hemp-derived cannabidiol in dietary...

Info Collection on Outsourcing Facility Challenges

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension for Obtaining Information to Understand Challen...

Watchdog Group Wants Teva Probe Transparency

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The watchdog group Accountable.US asks attorney general William Barr to be transparent about any political interference in a price...

Nominations for Compounding Advisory Committee

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Federal Register notice: FDA requests nominations for members to serve on its Pharmacy Compounding Advisory Committee.

FDA Updates Covid Screening Test Template

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FDA updates Covid-19 molecular test templates to help developers get tests authorized for broad screening of asymptomatic individu...

Chembio Covid-19 Antibody Test Authorization Revoked

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FDA revokes the emergency use authorization of a Chembio Diagnostic System Covid-19 antibody test due to performance concerns with...

FDA Warns 3 Companies on Covid Antibody Tests

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FDA warns three companies they are selling unapproved and misbranded Covid-19 antibody tests.