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FDA Fast Track for UroGens MitoGel

[ Price : $8.95]

FDA grants UroGen Pharma a fast track designation for MitoGel and its use in treating patients with low-grade upper tract urotheli...

In Vitro Diagnostic Device Chief Gutierrez to Retire

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CDRH Office of In Vitro Diagnostic Device Evaluation and Safety director Alberto Gutierrez announces his retirement.

Advisory Panel to Review Sparks Eye Therapy

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Federal Register notice: FDA announces a 10/12 Cellular, Tissue, and Gene Therapies Advisory Committee meeting.

CDRH Letter Outlines New User Fee Amounts

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CDRH sends out a letter to medical device establishments to provide information about device user fees, including fee rates and pa...

FDA Orders Seizure of Smallpox Vaccine Used in Cell Therapy

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On FDAs behalf, U.S. marshals seize five vials of Vaccinia Virus Vaccine (live) belonging to StemImmune Inc. (San Diego, CA), a va...

New FDA Crack Down on Unscrupulous Cell Therapy Clinics

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FDA announces new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine...

FDA Priority Review on La Jolla Hypotension Drug

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FDA accepts for priority review a La Jolla Pharmaceutical Co. NDA for the investigational drug LJPC-501 (angiotensin II) for treat...

FDA Approved Ortho BLA for Blood Grouping Reagents

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FDA approves an Ortho Clinical Diagnostics BLA for the Ortho Sera blood grouping reagents designed for extended phenotype testing ...

FDA Panel to Review Interstitial Cystitis Drug Development

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Federal Register notice: FDA announces a 12/7 Bone, Reproductive and Urologic Drugs Advisory Committee meeting.

FDA Warning Letters Drop on Potential Trump Effect

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FDA watchers worry that a significant recent drop in Warning Letters issued to medical product makers is a sign of President Donal...