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Integrate Key Teams for CNPV Success: Expert

[ Price : $8.95]

Veristat principal regulatory specialist John Kirk outlines FDAs Commissioners National Priority Voucher program and how sponsors ...

FDA Taps Tracy Beth Heg as Acting CDER Director

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FDA names physicianepidemiologist Tracy Beth Heg as CDER acting director, replacing director Richard Pazdur, who submitted his ret...

Former FDA Heads Warn on Prasads New Vaccine Policies

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A dozen former FDA commissioners warn that sweeping internal directives proposed by CBER director Vinay Prasad would undermine evi...

FDA Alert on Olympus Ligating Device Instructions

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FDA issues a device correction alert after Olympus recalled (Class 1) the instructions for its Single Use Ligating Device PolyLoop...

The Case for FDA Advisory Committees: Column

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provals managing director Steven Cohen lists the many benefits of FDA advisory committees even as the agency has reduced its use o...

Turalio Video Testimonial False or Misleading: OPDP

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The CDER Office of Prescription Drug Promotion says a Daiichi Sankyo promotional video patient testimonial for its Turalio mislead...

Rhyz Analytical Labs CGMP Violations

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FDA warns Provo, UT-based Rhyz Analytical Labs about CGMP violations in its work as a contract testing laboratory.

Multiple Turbare Manufacturing Violations

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FDA warns Conway, AR-based Turbare Manufacturing about CGMP and other violations in its work as an outsourcing facility producing ...

QTc Information Labeling Guidance

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FDA publishes a guidance to assist applicants in incorporating heart rate-corrected (QTc) interval of prolongation-related informa...

Judge Strikes Down FDA Decision Blocking Priority Voucher

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A Washington, DC, federal judge rules that FDA acted unlawfully when it denied a priority review voucher to Sun Pharma and its dru...