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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...

Guide on Assessing Drug User Fees

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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...

Stryker Trevo XP ProVue Retriever Recall is Class 1

[ Price : $8.95]

FDA says the Stryker Neurovascular recall of its Trevo XP ProVue Retriever due to a core wire that may break or separate during us...

CDER Finds Ways to Streamline Schizophrenia Drug Trials

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CDER researchers say it may be possible to streamline clinical trials for drugs to treat schizophrenia by cutting the trial length...

Comments Extended on Animal Drug Special Programs

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Federal Register notice: FDA extends the comment period on a 7/15 notice about a draft guidance #61 entitled Special Consideration...

Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company Nartex Laboratorios Homeopaticos.