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Combo Product Human Factors Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Application of Human Factors Engineering (HFE) Principles f...

Senators Reintroduce Opioid Studies Bill

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

GAO Report Probes Device DTC Advertising

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

Human Factors Engineering Q&A Guidance

[ Price : $8.95]

FDA publishes a guidance with questions and answers on applying human factors engineering principles in developing combination dru...