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Cardiac Profiler into Class 2

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Federal Register Final rule: FDA classifies cardiac allograft gene expression profiling test systems into Class 2 with a guidance ...

2 Computer-assisted Detection Device Draft Guidances Out

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FDA issues draft guidances on 510(k) and PMA submissions for computer-assisted detection devices applied to radiology images and d...

FDA Fast Track for Eye Drug

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FDA grants fast track status to MacuSight for Perceiva, an ocular sirolimus product intended for treating diabetic macular edema.

3rd Party Inspections are Only Answer to Drug Quality Worries

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Washington commentator Robert F. Steeves reflects on Bill Hubbards disclosure that 80% of U.S. drug ingredients come from abroad, ...

FDA Denies Approval of Kings CorVue

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FDA issues King Pharmaceuticals a complete response letter on its NDA for CorVue (binodenoson) for injection, a cardiac pharmacolo...

American Regent Recalls Ketorolac Tromethamine Injection

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American Regents recalls all lots of 1 mL and 2 mL single-dose vials of its ketorolac tromethamine injection.

Guidance on Tobacco Establishment Registration

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Federal Register Notice: FDA releases a draft guidance, Registration and Product Listing for Owners and Operators of Domestic Toba...

Two Draft Guidances on CADe for Radiology Images

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Federal Register Notice: FDA releases two draft guidances on computer-assisted detection devices applied to radiology images and r...

FDA OKs APP Pharmas Generic Diuril

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FDA approves an APP Pharmaceuticals ANDA for a generic copy of Lundbeck Pharmaceuticals Diuril (chlorothiazide sodium) for injecti...

Teva Files ANDA for Generic Nuvigil

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Cephalon says it received notice of an ANDA submission having been filed by Teva Pharmaceuticals for a generic copy of Nuvigil.