FDA
Industry Puzzles Over FDA's Medical App Regulation
FDA has been under pressure from Congress and IT firms to minimize its regulation of mobile medical apps (MMAs) to prevent stifling innovation in the burgeoning healthcare software field. In response, the agency has divided health-related IT products into three categories. But industry continues to puzzle over what MMAs fit into the middle “hands-off” area. Jill Wechsler reports
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“Drug Snapshots” Highlight Clinical Trial Demographics
Demands from patient advocacy groups for broader subgroup representation in clinical trials has generated a new drug trial transparency initiative at the Center for Drug Evaluation and Research (CDER) ...Read more
Digital Marketing According to HIPAA
How pharmaceutical companies can break through regulatory constraints to create personal, audience-driven marketing content
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Event
iPharma 2015 — CBI's Marketing Innovation Summit | May 14–15, New York, NY
Tap into the latest trends in life sciences technology, content and communications – only at iPharma 2015! Inspirational keynotes Jeremy Bloom and Rand Fishkin anchor the meeting along with industry leaders representing Novartis, GSK, Alcon, Boehringer, Lundbeck, GE Healthcare, BMS, Shire, Takeda, Biogen, Purdue, J&J, Pfizer, Bayer and many more! Plus, don't miss PharmExec's prestigious Brand of the Year unveiling during a special awards ceremony. Register now or learn more
Drug Safety
Staying Proactive in the Fight Against Counterfeiting
Counterfeiting remains a global, prevalent issue that has become increasingly difficult to police. Dave Campbell offers some tactics that pharma leaders can implement to stem the continued global threat of counterfeit drugs
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Drug Development
Finding and Funding the Cure for Alzheimer's Disease
The recent news of positive early stage trial results for Biogen's aducanumab has renewed hope for effective solutions for this devastating disease. However, many challenges remain in finding and funding new treatments, writes Ed Schoonveld
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 //REGENXBIO (Rockville, MD) announced that Luke M. Beshar has been appointed to its Board of Directors. Mr. Beshar will serve as the chairman of the company's audit committee.//BioDelivery Sciences International (Raleigh, NC) appointed Sarah DeRossett, MD, PhD to the position of Vice President of Clinical Research and Medical Affairs. //Joseph J. Sarret, M.D., J.D., joined Corium International (Menlo Park, CA) as Chief Business Officer.//Voyager Therapeutics (Cambridge, MA) promoted Jeff Goater to Senior Vice President, Finance and Business Development. // |
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