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Norlex Not Withdrawn Over Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Norflex (orphenadrine citrate) injection and extended-release tablets were not withdr...

10 Observations in Aurobindo Unit FDA-483

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FDA releases the form FDA-483 with 10 observations from an inspection at the Telangana, India-based Aurobindo Pharma Unit IX activ...

Non-Device Software Function Report

[ Price : $8.95]

The FDA Digital Health Center of Excellence publishes a 2022 report on non-device software functions.

Draft VMSR Guidance for Manufacturers

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FDA publishes a draft guidance to further explain but not change the Voluntary Malfunction Summary Program.

16 Observations on Lupin Unit FDA-483

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FDA releases the form FDA-483 with 16 observations from an inspection at the Pradesh, India-based Lupin Unit 1 drug manufacturing ...

FDA Proposes More Comprehensive IND Reports

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FDA publishes a proposed rule to make the investigational new drug annual reports more comprehensive and similar to those in other...

Draft Device Human Factors Guidance

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FDA publishes a draft guidance on the content of human factor and usability engineering information to be included in medical devi...

Comments on Pediatric Clinical Pharmacology Draft

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Two stakeholder associations comment on an FDA draft guidance on general clinical pharmacology considerations for pediatric studie...

Dewei Medical Recalls Sample Kits

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Dewei Medical Equipment recalls its DNA/RNA Preservation Kits because the products were distributed to U.S. customers without FDA ...

FDA Manuscript in the Works on Trial Diversity Strategy

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FDA commissioner Robert Califf says the agency is preparing a manuscript to outline a strategy for getting more diversity into cli...