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Duke Launches Real-World Evidence Collaborative

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The Duke Margolis Center for Health Policy announces a new Real-World Evidence Collaborative to support FDA in meeting real-world ...

Bayer Rebuts DeLauro Complaint on Essure Study

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Bayer vice president Steven Immergut disputes a complaint by Rep. Rosa DeLauro (D-CT) that the company has enrolled only one patie...

Gottlieb: Science Contributing to Inflection Point in Medicine

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FDA commissioner Scott Gottlieb says that across multiple science fields, we stand at an inflection point in medicine where new t...

Avanir Paid Disciplined Doctors to Promote Nudexta: CNN

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CNN says Avanir has paid some doctors facing disciplinary measures or criminal charges to promote its Nudexta.

Drug Spending Increase Lower than Last 2 Years: Report

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Federal actuaries say the annual increase in spending on prescription drugs nationally was lower in 2016 than in the previous two ...

Guide on Pediatric Rare Disease Drug Development

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Federal Register notice: FDA makes available a draft guidance entitled Pediatric Rare Diseases A Collaborative Approach for Drug ...

FDA Urges Primus Pharma to Recall Suspect Product

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FDA asks Primus Pharmaceuticals (Scottsdale, AZ) to recall Limbrel, a capsule marketed to manage the metabolic processes associate...

Most Post-Approval Studies On Track: Stein

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CDER Office of New Drugs deputy director Peter Stein says the backlog of post-marketing requirements and commitments has been dras...

Opinions Vary on Pre-DSHEA Supplement List

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Stakeholders suggest ways FDA can develop a list of pre-DSHEA dietary supplement ingredients or express concern that building such...

FDA Clears Camber Spine Interbody Fusion Implant

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FDA clears a Camber Spine 510(k) for the SPIRA-C Open Matrix Cervical Interbody device, an interbody fusion implant.