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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...

House OKs Rare Pediatric Disease Voucher Program

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The House approves legislation reauthorizing the FDA Pediatric Rare Disease Priority Review Voucher program and giving the agency ...

Monoclonal Antibody Streamlined Safety Study Guidance

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FDA publishes a draft guidance on streamlined nonclinical safety studies for monoclonal antibodies.

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...