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Civco Radiotherapy for Immobilization System

[ Price : $8.95]

FDA clears a Civco Radiotherapy 510(k) for its Solstice SRS Immobilization System.

Untitled Letter on Web Site Product Promotion

[ Price : $8.95]

CBER sends an untitled letter to the operator of two Web sites http://www.ollereg.com and http://www.innovativeallergy.com becau...

FDA Approves EyePoint Pharma Uveitis Drug

[ Price : $8.95]

FDA approves EyePoint Pharmaceuticals Yutiq (fluocinolone acetonide intravitreal implant) for treating chronic non-infectious uvei...

2 Guidances to Help Modernize Clinical Trials

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

BMS Opdivo Trial Misses Primary Endpoint in Lung Cancer

[ Price : $8.95]

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

[ Price : $8.95]

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