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Gene Therapy OKd for Blood Disorder

[ Price : $8.95]

FDA approves the first cell-based gene therapy for treating adult and pediatric patients with beta-thalassemia who require regular...

FDA Cybersecurity 2022 Guidance Explained

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Attorney Brynn Stanley outlines provisions in a 2022 FDA draft cybersecurity guidance and how they differ from the 2018 draft it r...

Brainstorm to File BLA for Lou Gehrigs Disease

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Brainstorm Cell Therapeutics says it will submit a BLA for it NurOwn stem cell therapy for treating amyotrophic lateral sclerosis.

Califf on New Ecosystem to Fight Disinformation

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FDA commissioner Robert Califf tells FDA Webview his agency is joining with other entities, especially universities, to form a new...

Guide on OTC Hearing Aids

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Federal Register notice: FDA makes available a final guidance entitled Regulatory Requirements for Hearing Aid Devices and Persona...

Circulating Tumor DNA Seen Useful in Cancer Treatment

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Cancer researchers say circulating tumor DNA may be an important tool in clinical development and an early indicator of treatment ...

Radiolabeled Mass Balance Study Comments

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Four stakeholders request clarification of parts of an FDA draft guidance on clinical pharmacology considerations for human radiol...

Comments on Drug Shortage Risk Guidance

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Two stakeholders request changes to an FDA draft guidance on risk management plans to mitigate the potential for drug shortages.

Guide on Contact Lens Hydrogen Peroxide Products

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FDA posts a draft guidance entitled Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations Premarke...

Makena NDA Withdrawal Hearing 10/17-19

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Federal Register notice: FDA grants a 10/17-19 hearing request to review and vote on whether agency approval for Covis Makena (hyd...