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2 Guidances to Help Modernize Clinical Trials

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As part of its continuing push to modernize clinical trials, FDA posts two guidance documents to provide greater clarity and recom...

PhRMA DTC Pricing Effort Aims to Stave Off Regulations

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Presumably to avert new FDA regulations about adding price information in direct-to-consumer ads, Pharmaceutical Research and Manu...

Guide on Revised Common Rule Implications

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FDA posts a guidance entitled Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.

Notice on Pathogen Reduction Workshop Corrected

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Federal Register notice: FDA corrects a 9/17 notice announcing an 11/29 public workshop entitled Pathogen Reduction Technologies f...

Grifols Test OKd for Blood Group Genotyping

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FDA approves Grifols ID Core XT molecular diagnostic test for blood group genotyping.

BMS Opdivo Trial Misses Primary Endpoint in Lung Cancer

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Bristol-Myers Squibb reports disappointing topline results from its Phase 3 CheckMate-331 study evaluating Opdivo (nivolumab) vers...

FibriCheck Smartphone App Cleared for Heart Rhythm

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FDA clears a FibriCheck 510(k) for its smartphone application that monitors heart rhythm disorders by using an optical signal orig...

Sutro Biopharma Orphan Status for Multiple Myeloma Therapy

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FDA grants Sutro Biopharma an orphan drug designation for STRO-001 for treating multiple myeloma.

Panel Gives Mixed Vote on Trevena Pain Drug

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FDAs Anesthetic and Analgesic Drug Products Advisory Committee votes 8 to 7 to recommend not approving Trevenas next-generation op...

Require High-Quality Device Evidence: Blog

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Cardiologist Rita Redberg says in a Health Affairs online post that FDA should require high-quality evidence for approval of medic...