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Nanowears SimpleSense Undergarment Monitor Cleared

[ Price : $8.95]

FDA clears a Nanowear 510(k) for its cloth-based diagnostic platform SimpleSense, a multi-parameter remote diagnostic undergarment...

Lilly Gets EUA for Covid Antibody Treatment

[ Price : $8.95]

FDA grants Eli Lilly an emergency use authorization for its investigational monoclonal antibody therapy bamlanivimab for treating ...

CGMP Violations at Nartex Laboratories

[ Price : $8.95]

FDA warns Mexicos Nartex Laboratories about CGMP violations in its production of finished drugs.

Positive Trial Results for Amgens Tezepelumab

[ Price : $8.95]

Amgen and AstraZeneca say their investigational asthma drug tezepelumab achieved positive results in the Phase 3 NAVIGATOR trial.

Senators Want Info on FDA Foreign Drug Inspections

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Sens. Warren and Smith ask FDA for information on what it needs to adequately conduct foreign drug inspections during the pandemic...

Guide on Assessing Drug User Fees

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Federal Register notice: FDA makes available a revised final guidance on Assessing User Fees Under the Prescription Drug User Fee ...

Guide on Microneedling Product Regulatory Considerations

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Regulatory Considerations for Microneedling Products.

Diversity in Trials Final Guidance

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Federal Register notice: FDA makes available a final guidance entitled Enhancing the Diversity of Clinical Trial Populations Elig...

Supernus Talking with FDA on Two Submissions

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Supernus Pharmaceuticals says it has received a complete response letter and refusal to file letter from FDA for two NDAs and will...

OPDP Revising Drug Promo Core Launch Reviews

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CDER Office of Prescription Drug Promotion acting director Catherine Gray says that beginning next year the Office is revising its...