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Lensar Astigmatism Management Feature Cleared

[ Price : $8.95]

FDA clears a Lensar 510(k) for its IntelliAxis-L, the companys latest astigmatism management feature to guide toric intraocular le...

FDA Clears Neusoft Medical New CT Scanner

[ Price : $8.95]

FDA clears a Neusoft Medical Systems 510(k) for its new 128-slice NeuViz Prime CT scanner.

Heron NDA for Nausea Drug Approved

[ Price : $8.95]

FDA approves a Heron Therapeutics NDA for Cinvanti (aprepitant) injectable emulsion, a P/neurokinin-1 receptor antagonist indicate...

FDA Harmonizing MDR Adverse Event Coding with Other Regulators

[ Price : $8.95]

As part of an adverse event harmonization effort, FDA says it is no longer adding new adverse event codes for Medical Device Repor...

Teligent ANDA for Betamethasone Dipropionate Approved

[ Price : $8.95]

FDA has approved a Teligent ANDA for a generic copy of Promius Pharmas Sernivo, indicated for treating mild-to-moderate plaque pso...

FDA Hits Lupin with Warning on 2 Indian Facilities

[ Price : $8.95]

FDA issues a combined Warning Letter to India-based Lupin after two drug manufacturing facilities at Goa and Indore were inspected...

Comments Sought on Condom Labeling Info Collection

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection for Class II Special Controls Guidance Document: Labeling...

Upcoming Blood Products Advisory Committee Meeting

[ Price : $8.95]

Federal Register notice: FDA announces an 11/30 to 12/1 Blood Products Advisory Committee advisory committee meeting.

Insys Wants Generic Syndros Requirements

[ Price : $8.95]

Insys Therapeutics asks FDA not to approve any ANDA for generic Syndros based on an agency waiver of bioequivalence testing.

Motor Vehicle Drug Effect Guidance

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FDA publishes a guidance to help drug sponsors evaluate the effects of psychoactive drugs on the ability to operate a motor vehicl...