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FDA Denies Petition Seeking New Opioid Moratorium

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FDA denies a 3/21 citizen petition from advocacy group Public Citizen that urged the agency to immediately impose a moratorium on ...

2 FDA Guidances on De Novo Device Requests

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FDA issues two guidances related to medical device de novo classification requests one on performance goals and the other on user...

FDA Hits Juul with Warning Letter

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FDA issues a Warning Letter to Juul Labs over marketing unauthorized modified risk tobacco products.

FDA Quality Guide on Real World Data Coming

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FDA says it is developing guidance on data quality issues that pertain to real world data and related study design considerations.

GAO Report on Patient Access to Investigational Drugs

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A new GAO report finds that FDA has ongoing efforts to help drug manufacturers identify the circumstances under which they could b...

Reg Review Period for Glaxos Shingrix Vaccine

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Federal Register notice: FDA determines the regulatory review period for patent extension purposes for GlaxoSmithKline Biologicals...

Guide on Humanitarian Device Exemption Program

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Federal Register notice: FDA makes available a final guidance entitled Humanitarian Device Exemption (HDE) Program.

Priority Voucher Used on Rinvoq Approval

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Federal Register notice: FDA announces that it accepted a priority review voucher to approve AbbVies Rinvoq (upadacitnib) on 8/16....

Woodcock Urges Better Drug Compounding Safety Reports

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CDER director Janet Woodcock urges drug compounding outsourcing facilities to appropriately label their drugs with adverse event r...

Guide on Acceptance Review for De Novo Devices

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FDA issues a final guidance entitled Acceptance Review for De Novo Classification Requests.