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Fiscal Year 2018 Generic User Fees Set

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Federal Register notice: FDA announces fiscal year 2018 rates for generic drug user fees.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Hetero Labs Limited and Total Nutrition.

Leica Microsystems Gains Clearance for Microscope Filter

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FDA clears a Leica Microsystems 510(k) for its FL560 fluorescence microscope filter for visualizing cerebrovascular blood flow in ...

FDA Fast Track for UroGens MitoGel

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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...