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Federal Register

2 Priority Review Vouchers Issued

Federal Register notices: FDA issues two priority review vouchers to sponsors whose recent product approvals met the criteria (rare pediatric disease ...

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Biologics

FDA Update on Bone Matrix TB Issue

FDA says it is working with the CDC to investigate cases of TB associated with a bone matrix product.

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Federal Register

3 Draft Guides on 510(k) Devices

Federal Register notice: FDA releases three draft guidances that are intended to improve the predictability, consistency, and transparency of the 510(...

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Federal Register

Panel to Discuss Sickle Cell Therapy

Federal Register notice: FDA announces a 10/31 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to review a Vertex Pharmaceuticals BLA ...

Human Factors Engineering Q&A Guidance

FDA publishes a guidance with questions and answers on applying human factors engineering principles in developing combination drug products.

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Human Drugs

Suggestions for ICH Good Clinical Practice Guideline

Four stakeholder groups suggest revisions to an FDA publication of the ICH E6(R3) good clinical practice guideline.

Biologics

Strong Response in New Moderna Covid Vaccine

Moderna says its updated Covid-19 vaccine demonstrated a strong response against the new BA.2.86 variant that is being closely watched due to having o...

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Human Drugs

FDA, Flatiron Health Real-world Data Pact

FDAs Oncology Center of Excellence and Flatiron Health renew a five-year collaboration to jointly develop and implement specific research projects to ...

Medical Devices

Breakthrough Status on Auto Glucose Device

FDA grants Admetsys a breakthrough device designation for its automated glucose control and continuous blood diagnostics system.

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Medical Devices

3 New 510(k) Guidances

FDA posts an update on changes being made to the 510(k) program through three draft guidances.