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Comments Extended for Gene Therapy Guidances

[ Price : $8.95]

Federal Register notice: FDA extends the comment period on six draft guidance documents about developing human gene therapy produc...

Guide on Uncertainty in Device Benefit-Risk Determinations

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Consideration of Uncertainty in Making Benefit-Risk Determi...

AMDT Holdings 510(k) for Deformity Analyzer

[ Price : $8.95]

FDA clears an AMDT Holdings 510(k) for its SixFix deformity analysis and correction software and instrumentation.

Beaumont Bio Recalls Contaminated Product Line

[ Price : $8.95]

Beaumont Bio Med recalls its entire aqueous/alcohol-based product line due to possible microbial contamination.

Draft Device Uncertainty Determination Guidance

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FDA issues a draft guidance describing its approach to considering uncertainty in making benefit/risk decisions for some medical d...

Allergic, Nonallergic Rhinitis Guidances Out

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FDA publishes guidances to assist sponsors in developing drugs to treat allergic rhinitis and nonallergic rhinitis.

CDER Inspection Site Selection Model MAPP

[ Price : $8.95]

CDER issues a MAPP on policies and procedures for the site selection model used by the Office of Surveillance to prioritize manufa...

PhRMA Analysis Finds Hospitals Jacking Up Drug Prices

[ Price : $8.95]

A new analysis commissioned by PhRMA shows that about one in five hospitals marks up medicine prices 700% or more.

Info Collection Extension for Drug Supply Chain Guide

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Guidance for Industry: Drug Supply Cha...

Remove Contrast Agent Boxed Warning: ICUS

[ Price : $8.95]

The International Contrast Ultrasound Society says current safety information does not justify use of Boxed Warnings in the produc...