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Depomed Planning NDA for 'Hot Flashes' Drug

[ Price : $8.95]

Depomed says it will meet with FDA to discuss a planned NDA after announcing positive clinical trial results from a Phase 3 study ...

Bill Aims to Cut Device Regulatory Burden

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Three senators introduce a bill to streamline FDA regulation of medical devices.

Micromet Revises Leukemia Drug Plan Based on FDA Advice

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Micromet says it has revised its clinical development plan based on recent FDA advice for its lead product candidate blinatumomab ...

FDA Clears CorMatrix Carotid Repair Device

[ Price : $8.95]

FDA clears a CorMatrix Cardiovascular 510(k) for the CorMatrix Extracellular Matrix (ECM) for Carotid Repair.

PDA Praises Flexibility in ICH Q11

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The Parenteral Drug Association praises manufacturer flexibility built into International Conference on Harmonization Q11 guidance...

Reps Want to Look at Medical Device Regs

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Democratic leaders of the House Energy and Commerce Committee target CDRH medical device review and postmarket surveillance perfor...

Coopers Says it is Completing Recall

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CooperVision says it is cooperating with FDA to complete an August recall of certain Avaira Toric contact lenses.

NIH Head Sees Big Promise for Orphan Drugs in DNA Cost Drop

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NIH director Francis Collins explains that a dramatic reduction in cost for DNA sequencing holds profound promise for developing n...

FDA Severely Damages Device Industry Creativity: Lawyer

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In a Competitive Enterprise Institute issue analysis, noted medical device lawyer Larry Pilot criticizes what he describes as poor...

Bayer, Onyx Revise Agreement on Cancer Drugs

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Bayer Healthcare and Onyx Pharmaceuticals enter into a new agreement related to regorafenib, a late-stage oncology compound, and N...