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FDA Approves Boston Scientific Watchman FLX

[ Price : $8.95]

FDA approves Boston Scientifics Watchman FLX left atrial appendage closure device.

HCT/P Manipulation and Homologous Use Guidance

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FDA issues a guidance with its current thinking on the regulatory criteria for human cells, tissue, and cellular and tissue-based ...

Paige Digital Pathology Viewer Cleared

[ Price : $8.95]

FDA clears a Paige 510(k) for the FullFocus, a digital pathology image viewer for the purpose of primary diagnosis.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Centurion Medical Products, Signa SA de CV facility and Stason Phar...

CGMP Violations at Stason Pharmaceuticals

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FDA warns Stason Pharmaceuticals about CGMP violations in its production of finished drugs.

Enforcement Discretion Extended on Regenerative Therapies

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FDA extends by six months its enforcement discretion policy for certain human cell, tissue, and cellular and tissue-based products...

FDA Tightening Internal Lab Safety

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FDA says it is currently reviewing its internal laboratory safety program to align with ongoing, shifting, and future priorities.

Acadia sNDA for Dementia-related Hallucinations

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FDA accepts for review an Acadia Pharmaceuticals supplemental NDA for Nuplazid (pimavanserin) for treating hallucinations and delu...

Pfizer, BioNTech Positive Data on Covid Vaccine Program

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Pfizer and BioNTech report positive data from an ongoing German Phase 1/2 trial involving its mRNA-based BNT162 coronavirus vaccin...

FDA EUA for 1st Pooled Covid Test

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FDA reissues an emergency use authorization to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR test for pooled Covid-1...