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FDA Modifies Partial Hold on Davet Syndrome Drug

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FDA modifies a partial clinical hold against Stoke Therapeutics to allow the administration of a higher single dose of STK-001 (70...

Info Collection on Radioactive Drug Research

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Federal Register notice: FDA seeks comments on an information collection extension entitled Radioactive Drug Research Committees ...

6 No-Longer-Marketed ANDAs Withdrawn

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Federal Register notice: FDA withdraws approval of six ANDAs from multiple applicants after they notified the agency that the prod...

Bill to Streamline Generic Drug Approvals

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Sens. Paul and Hassan reintroduce their bill to require FDA to more clearly identify differences between generic drugs that have b...

Former Drug Sales Rep Pleads Guilty

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The Department of Justice says former drug sales representative Vincent Tornari pled guilty to one count of healthcare fraud and w...

FDA Reviewers Seem Positive on Paxlovid NDA

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An FDA advisory committee briefing document says data support the efficacy of Pfizers Paxlovid (nirmatrelvir and ritonavir) for tr...

Mixed Stakeholder Views on Orange Book Listings

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The Government Accountability Office says 15 stakeholders had widely varying views on the listing of drug/device combination produ...

FDA Issues 2 Priority Review Vouchers

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Federal Register notice: FDA issues two priority review vouchers to the sponsors of recent rare pediatric disease product applicat...

Local Anesthetic Drug Guidance

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FDA publishes a draft guidance with information for sponsors who are developing certain local anesthetic drug products to produce ...

PhRMA Comments on Drug Labeling Guidance

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PhRMA suggests changes to an FDA revised draft guidance on the content and format of the Dosing and Administration section of drug...