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DTC Research Raises Concern on Endpoints in Cancer Ads

[ Price : $8.95]

New research on drug direct-to-consumer television advertising finds that viewers misinterpreted certain oncology clinical trial e...

Priority Review Voucher Awarded to Pharming Tech

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Federal Register notice: FDA issues a priority review voucher to Pharming Technologies that was related to its rare pediatric dise...

Priority Review Voucher Awarded to Pharming Tech

[ Price : $8.95]

Federal Register notice: FDA issues a priority review voucher to Pharming Technologies that was related to its rare pediatric dise...

FDA Updates Alert on O&M Halyard N95 Masks

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FDA provides further clarification about a safety alert issued earlier this month that recommended against the use of certain surg...

Guide on Radiation Syndrome Drug Development

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Federal Register notice: FDA makes available a draft guidance entitled Acute Radiation Syndrome: Developing Drugs for Prevention a...

10 Observations in Lupin FDA-483

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FDA releases the form FDA-483 with 10 observations from a recent inspection at a Lupin drug manufacturing facility in Pithampur, I...

Sarepta Comments on Golodirsen PSG

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Sarepta raises several points for FDA consideration on an agency draft product-specific guidance for golodirsen.

GE Healthcares Carescape Patient Monitor Cleared

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FDA clears a GE HealthCare 510(k) for its Carescape Canvas patient monitoring platform for precise, flexible patient care.

FDA Describes New QSAR Model

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An FDA online post describes research creating new quantitative structure-activity relationship models to predict blood-brain barr...

FDA Failed to Collect $45 bil. Drug Trial Fines: Students

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Johns Hopkins students who belong to Universities Allied for Essential Medicines say FDAs failure to fine companies that dont subm...