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Woodcock Upheld by Califf in Duchenne Drug Appeal

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In an unprecedented move, FDA commissioner Robert Califf upholds CDER director Janet Woodocks unusual role in reviewing and approv...

FDA Rescinds Teva SPA After Dosing Changed

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FDA rescinds a Teva Pharmaceutical Industries Special Protocol Assessment after two dosing options were discontinued in multiple s...

FDA, University of MD Host Clinical Investigator Training

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Federal Register Notice: FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation plans a thre...

FDA Approves Device for Clogged Ear Disorder

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FDA approves an Acclarent de novo petition to permit marketing of the Aera Eustachian Tube Balloon Dilation System for treating pe...

Firm Petitions for Adding Chromium to OTC Acne Monograph

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Metabolic Therapy Inc. petitions FDA to amend the Over-the Counter Acne Drug Products monograph for active ingredients to indicate...

Drug Marketers Digital Efforts Eclipse Traditional Detail Visits

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Marketing consultant ZS Associates report that drug company digital and non-personal contacts are on the rise as sales representat...

ICH Guidance on Nonclinical Studies for Anticancer Agents

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FDA posts an International Conference on Harmonization draft guidance on S9 Nonclinical Evaluation for Anticancer Pharmaceuticals...

HHS, NIH Move to Increase Clinical Trial Transparency

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HHS issues a new rule and the National Institutes of Health issues a new policy, both intended to increase the availability of cli...

FDA Mulls New Clinical Trial Eligibility Criteria: Pazdur

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FDA Oncology Center of Excellence acting director Richard Pazdur says his Center is working with stakeholders to revisit criteria ...

Comments Sought on Unique Device Identifier Requirements

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Federal Register Notice: FDA seeks comments on a proposed collection of information related to the agencys Unique Device Identific...