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Daiichi Sankyo Breakthrough Status for Leukemia Therapy

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FDA grants Daiichi Sankyo a breakthrough therapy designation for quizartinib, an investigational FLT3 inhibitor for treating adult...

6 Observations in Sharp Drug FDA-483

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FDA releases the FDA-483 with six observations from a Sharp Drugs inspection.

Group Wants FDA to Regulate Only Through Regulations

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The New Civil Liberties Alliance asks FDA to adopt a rule that would require the agency to regulate only through notice-and-commen...

FDA Antimicrobial Stewardship Blueprint Coming

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FDA commissioner Scott Gottlieb says the agency is working on a new CVM five-year plan to advance antimicrobial stewardship in vet...

CGMP Deviation at Yuki Gosei Kogyo

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FDA warns Japans Yuki Gosei Kogyo about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

Medical Device User Fees for FY 2019 Set

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Federal Register notice: FDA announces the fee rates and payment procedures for medical device user fees for fiscal year 2019.

Biosimilar User Fee Rates Established

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Federal Register notice: FDA announces the rates for biosimilar user fees for fiscal year 2019.

Homeopathic Drugs Not New Drugs: Trade Group

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Americans for Homeopathic Choice asks FDA to reconsider its petition that homeopathic drugs will be considered to be new drugs.

Milbar Laboratories CGMP Violations

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FDA warns Milbar Laboratories about CGMP violations in its manufacturing of finished pharmaceuticals.

Draft Fluticasone Propionate Guidance

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FDA publishes a draft guidance on in vitro and in vivo studies to establish bioequivalence of the test and reference metered dose ...