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Pilot Considered on Evaluating Novel Excipients

[ Price : $8.95]

Federal Register notice: FDA establishes a docket to obtain information and comments that will assist it in determining whether to...

CDRH Industry Basics Webcast

[ Price : $8.95]

A CDRH Industry Basics webcast gives basic program information on the 513(g) device determination and classification process and t...

Reg Review Period for Sparks Luxturna

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Spark Therapeutics Luxturna...

Jobs Lost if Medical Device Tax Not Repealed: Analysis

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AdvaMed says that if Congress does not repeal the medical device tax before the end of the year, more than 20,000 industry jobs wi...

FDA Should Consider Free Speech Decisions: MIWG

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The Medical Information Working Group says FDA should incorporate principles from five recent Supreme Court free speech decisions ...

Oncology Panel Review AstraZeneca, Merck

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Federal Register notice: FDA announces a 12/17 Oncologic Drugs Advisory Committee meeting that with discuss an AstraZeneca supplem...

Rising Pharma Paying Over $3 Million in Price Fixing Charge

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The Justice Department says Rising Pharmaceuticals will pay over $3 million to resolve price fixing charges and will cooperate wit...

Tecentriq/Chemo Combo OKd for Lung Cancer

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FDA approves a Genentech supplemental BLA for Tecentriq (atezolizumab) in combination with chemotherapy for the initial treatment ...

House Drug Price Bill Keeps New Drugs Away: White House

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The White House Council of Economic Advisors cautions that House Democrats drug price bill will keep innovative new drugs off the ...

Breakthrough for RightEye Parkinsons Test

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FDA grants RightEye a breakthrough device designation for the RightEye Vision System and its use in diagnosing Parkinsons Disease....