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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...

Zilver Stent Safe, Effective: Reviewers

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FDA asks the Circulatory Systems Devices Advisory Panel members whether they believe the Cook Zilver peripheral artery coated sten...

FDA Grant Seeks to Advance Pediatric Devices

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FDA awards Georgia Tech, Childrens Healthcare of Atlanta, Emory University and Saint Josephs Translational Research Institute (SJT...

FDA Adds New Information Chief from J&J

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Former Johnson & Johnson Pharmaceutical R&D chief information officer (CIO) Eric Perakslis joins FDA as its new CIO.

Dont Approve Ferriprox: Public Citizen

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Public Citizen calls on FDA not to approve ApoPharmas Ferriprox because the company has failed to demonstrate the drugs safety and...