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Senators Reintroduce Opioid Studies Bill

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U.S. Senators Joe Manchin (D-WV) and Mike Braun (R-IN) reintroduce their bipartisan FDA Review of Efficacy EERW Double-Blinds (FRE...

House Committee Hearing on Drug Shortages

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The House Energy and Commerce Committee announces a 9/14 legislative hearing to discuss legislative proposals on preventing generi...

IRB Review of Expanded Access Request Guide

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FDA posts a guidance entitled Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Invest...

Subcutaneous Tecentrig Delayed Due to CMC Info

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FDA requests updated chemistry, manufacturing and controls information on Genentechs subcutaneous formulation of lung cancer drug ...

GAO Report Probes Device DTC Advertising

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In what is a likely sign of increasing interest on Capitol Hill, the Government Accountability Office releases a new report examin...

Panel to Review Merck Cough Drug

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Federal Register notice: FDA announces an 11/17 Pulmonary-Allergy Drugs Advisory Committee to review a Merck NDA for gefapixant or...

Meeting on Kidney Transplant Rejection Drugs

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Federal Register notice: FDA plans an 11/9 public meeting entitled Endpoints and Trial Designs to Advance Drug Development in Kidn...

Danco Seeks High Court Abortion Drug Review

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Abortion drug distributor Danco Laboratories petitions the U.S. Supreme Court to review last months decision by the Fifth Circuit ...

ISO 10993-1 Clarifying Guidance

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FDA publishes a guidance clarifying and updating information on using ISO 10993-1 in preparing medical device submissions to FDA.

No Marketing of Same Rx and OTC Drugs: Reps

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A bipartisan group of three House members asks CDER to remove the simultaneous marketing provision from a proposed rule on Rx to O...