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Servicing/Remanufacturing White Paper, Workshop

[ Price : $8.95]

FDA issues a white paper outlining issues to be discussed at a December workshop on the distinctions between medical device servic...

Rocky Mountain Orthodontics Gains Orthocaps Clearance

[ Price : $8.95]

FDA clears a Rocky Mountain Orthodontics 510(k) for Orthocaps, a transparent and removable appliance for correcting tooth malposit...

Tanezumab Study Meets Efficacy Endpoints

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Pfizer and Lilly say a Phase 3 trial of their novel osteoarthritis monoclonal antibody met all three co-primary efficacy endpoints...

Genentech Flu Drug Approved by FDA

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FDA approves Genentechs Xofluza (baloxavir marboxil) for treating acute, uncomplicated influenza in people 12 years of age and old...

Joint Panel to Mull Increasing Naloxone in Communities

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Federal Register notice: FDA announces a 12/17 joint advisory committee meeting to discuss strategies to increase the availability...

2007 FDA Law Brought Better Trial Reporting: Study

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A new study concludes that the FDA Amendments Act (FDAAA) of 2007 has led to more clinical trials being registered and results bei...

Regulatory Review Period Determined for Lartruvo

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Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Imclones Lartruvo.

Testicular Toxicity Draft Guidance

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FDA publishes a draft guidance to assist sponsors who develop drug products that may result in testicular toxicity.

20 Years of FDA Innovation

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FDA deputy commissioner Anna Abram tells the JAX Healthcare Forum how innovation is part of FDAs DNA.

Regulatory Review Period Determined for Tecentriq

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Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Genentechs Tecentri...