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Bipartisan Legislation on Patent Listings

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Bipartisan lawmakers introduce legislation in the Senate and House to close a patent-listing loophole that drug manufacturers use ...

Panel Backs Expanded Onpattro Use

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An FDA advisory committee votes 9 to 3 that the benefits of Alnylam Pharmaceuticals patisiran (Onpattro) outweigh its risks for tr...

FDA Questions Efficacy of Patisiran sNDA

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FDA medical reviewers question the efficacy of Alnylam Pharmaceuticals patisiran for an expanded population sought in an sNDA.

FY 2022 GDUFA Science, Research Outcomes

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FDA publishes its FY 2022 report on GDUFA science and research outcomes.

Safecor Health CGMP Violations

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FDA warns Safecor Health that its Columbus, OH-based drug manufacturing facility has significant violations of CGMP requirements f...

Similasan Marketing Unapproved New Drugs: FDA

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FDA warns Switzerlands Similasan AG that it is marketing unapproved new ophthalmic drugs that are manufactured with significant CG...

FDA Warns 8 Firms for Unapproved Eye Drugs

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FDA warns eight companies that they are illegally marketing unapproved ophthalmic drugs.

CDER Defends Pepaxto Withdrawal Proposal

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CDER says the legal standard for withdrawing Oncopeptides ABs Pepaxto has been met and the agency should withdraw the drug to prot...

2 FDA Recommendations in Patient Safety Report

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A Presidents Council of Advisors on Science and Technology report on patient safety includes two recommendations for FDA action.

White Paper on Preventing Drug Shortages

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A white paper by the Duke Margolis Center for Health Policy calls for a new government coordinating effort, the Prevent Drug Short...