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CGMP Issues in China University Contract Lab

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FDA warns Chinas Center for Instrumental Analysis of China Pharmaceutical University about CGMP deviations in its work as a contra...

Trokamed Sheath Instructions Update is Class 1: FDA

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FDA says a Trokamed recall updating instructions for its Mini PCNL sheath was Class 1.

Supernus Wins OK for Parkinsons Drug

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FDA approves a Supernus Pharmaceuticals NDA for Onapgo (apomorphine hydrochloride) injection for treating motor fluctuations in ad...

Bard Pays $17 Million to Resolve Kickback Charges

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The Justice Department says C.R. Bard and three affiliates have agreed to pay $17 million to resolve a whistleblowers allegations ...

Feds Sued Over Removing Web Site Health Info

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Represented by Public Citizen Litigation Group, Doctors for America sues FDA and several other agencies over their removal of Web ...

Lumitron Get Breakthrough Status for New X-Ray

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FDA grants Lumitron Technologies a breakthrough device designation for its HyperVIEW X-Ray system for contrast-enhanced imaging fo...

RFK Jr.'s HHS Nomination Moves to Senate Floor

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HHS secretary-nominee Robert F. Kennedy Jr.s nomination moves one step closer to completion after the Senate Finance Committee vot...

Global Calcium CGMP Deviations

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FDA warns Indias Global Calcium about CGMP deviations in its manufacture of active pharmaceutical ingredients.

Susvimo OKd for Diabetic Macular Edema

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FDA approves a Genentech supplemental BLA for Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic macular edema.

Gyder Hip System Cleared by FDA

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FDA clears a Gyder Surgical 510(k) for the Gyder Hip System and its use in positioning the acetabular cup during hip replacement s...