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GAO Report on Patient Access to Investigational Drugs

[ Price : $8.95]

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.

Review Period Determined for Giapreza

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Federal Register notice: FDA determines the regulatory review period for La Jolla Pharmaceuticals Giapreza (angiotensin II).

Guide on Pediatric Partial Onset Seizures

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Federal Register notice: FDA makes available a final guidance entitled Drugs for Treatment of Partial Onset Seizures: Full Extrapo...

Info Collection Extension for GCP Guide

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension for Guidance for Industry on E6 (R2) Good Clini...

Bardy Diagnostic 14-day P-wave Monitor Cleared

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FDA clears a Bardy Diagnostics 510(k) for its 14-Day version of the Carnation Ambulatory Monitor, a P-wave heart monitor.