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AstraZeneca U.S. Covid Vaccine Trial Expected to Resume

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Covid-19 vaccine watchers expect FDA to soon remove a clinical hold on AstraZenecas Covid-19 vaccine trial after it completed its ...

CGMP Violations at RLC Labs

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FDA warns RLC Labs about CGMP and other violations in its production of unapproved biologic products.

Merck Positive Data on Pneumococcal Conjugate Vaccine

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Merck reports positive findings from two Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, the compa...

OMB Calls for Enforcement Best Practices

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Three Hyman, Phelps attorneys say one good thing to come out of the pandemic could be FDA adoption of principles of fairness in an...

FDA Debars Komar for 5 Years

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Federal Register notice: FDA issues an order debarring Keith Komar for five years from importing or offering for import any drug i...

Guidance on FDA 3988 and 3989

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FDA issues a draft guidance on how to use and submit forms FDA 3988 and 3989 for certain postmarketing studies or clinical trials.

FDA Pandemic Oncology Drug Development Support

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Three FDAers explain how the Oncology Center of Excellence has worked with clinical trial sponsors to find ways to safely continue...

California Will Do Its Own Covid Vaccine Review

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California names a Scientific Safety Review Workgroup charged with independently evaluating any Covid-19 vaccine approved by FDA b...

FDA Accepts Tagrisso sNDA, Grants Priority Review

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FDA accepts an sNDA for AstraZenecas Tagrisso cancer drug and will give it priority review.

Ezra Artificial Intelligence Cleared For Prostate MRI Scans

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FDA clears an Ezra 510(k) for its artificial intelligence and its use in assisting radiologists in their analysis of prostate MRI ...