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Info Collection on e-Import Entries Revised

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Federal Register notice: FDA sends to OMB an information collection revision entitled Imports and Electronic Import Entries.

FDA Withdraws Oxandrolone NDA/ANDAs

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Federal Register notice: FDA withdraws the approval of a Gemini Laboratories NDA for Oxandrin (oxandrolone) tablets and four ANDAs...

Supply Chain Violations at Safe Chain Solutions

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FDA warns Cambridge, MD-based Safe Chain Solutions about violations of the Drug Supply Chain Security Act in its work as a wholesa...

DTC Efficacy and Risk Information Guidance

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FDA publishes a guidance on how to present more consumer-friendly efficacy and risk information in direct-to-consumer promotional ...

QCARD Can Improve Oncology Submissions

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Two Oncology Center of Excellence executives describe the benefits of the new QCARD initiative intended to improve study proposals...

Schumer Pushes Drug Shortage Legislation

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Senate majority leader Chuck Schumer says FDA must develop a plan to deal with drug shortages and Congress must pursue a legislati...

Wholesaling Prohibition Guidance

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FDA publishes a draft guidance about the prohibition on wholesaling of compounded drugs under Section 503B of the Federal Food, Dr...

Complete Response on Higher Dose Eylea

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FDA issues a complete response letter on a Regeneron Pharmaceuticals BLA for Eylea (aflibercept 8 mg), a higher dose of the eye dr...

UCBs Rystiggo Approved for Myasthenia Gravis

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FDA approves a UCB BLA for Rystiggo (rozanolixizumab-noli) for treating generalized myasthenia gravis in certain adult patients.

Implant Sales Rep Arrested in Fraud Case

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The U.S. government arrests former DePuy Synthes sales representative Matthew Capobianco on eight counts of wire fraud and one cou...