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QS, MDR Violations at Datascope

[ Price : $8.95]

FDA warns Datascope Corp. about Quality System and Medical Device Reporting violations in its manufacturing of several medical dev...

FDA Revises 505(q) Petition Guidance

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FDA commissioner Scott Gottlieb says a revised draft guidance should improve the predictability and efficiency of generic drug rev...

Panel to Hear DNA Virus Lab Research

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Federal Register notice: FDA announces an 11/8 Vaccines and Related Biological Products Advisory Committee meeting to hear an over...

Lilly Plans 2019 NDA for Diabetes Therapy URLi

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Eli Lilly plans to submit an NDA for Ultra Rapid Lispro in 2019 after reporting favorable clinical trial data from two Phase 3 tri...

Special 510(k) Program Draft Guidance

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Federal Register notice: FDA issues a draft guidance entitled The Special 510(k) Program.

FDA Debars Richard Fleming Due to Fraud Probe

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Federal Register notice: FDA issues an order to debar Richard M. Fleming for 10 years from providing services in any capacity to a...

PET Drug CGMP Violations at N-Molecular

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FDA warns N-Molecular about CGMP violations in its production of PET drugs.

Guide on Atopic Dermatitis Pediatric Studies

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FDA posts a guidance entitled Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs.

Package Type Guidance

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FDA issues a guidance with recommendations for selection of appropriate package type terms and appropriate discard statements for ...

Optimize Emergency Trial Pathway for Public Trust: Study

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Researchers suggest a change in FDA reporting requirements for exception from informed consent clinical trials to better describe ...