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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...

Uncertainty in Making Device Benefit-Risk Determinations Guide

[ Price : $8.95]

CDRH releases a draft guidance entitled Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Prema...

2 New Private Payor Program Participants

[ Price : $8.95]

FDA commissioner Scott Gottlieb praises the growth of the agencys medical device Private Payor Program that aims to shorten the ti...

CDRH Seeks Members for Radiation Safety Panel

[ Price : $8.95]

Federal Register notice: FDA seeks nominations for members to serve on CDRHs Technical Electronic Product Radiation Safety Standar...

Pfizer Alopecia Therapy Granted Breakthrough

[ Price : $8.95]

FDA grants Pfizer a breakthrough therapy designation for its investigational oral Janus kinase 3 inhibitor PF-06651600 for treatin...

Captiva Spine 3D-Printed Lumbar Cages Cleared

[ Price : $8.95]

FDA clears a Captiva Spine 510(k) for its TirboLOX-L 3D-Printed Titanium Lumbar Cages.

FDA Launches Quik Review 510(k) Pilot

[ Price : $8.95]

FDA launches a Quik Review Program pilot to reduce the maximum time for a 510(k) product application decision.