Category Archives: FDA

Suffer Little Children? To Medicate or Not to Medicate Toddlers

When Audre McDonald accepted her sixth Tony Award (theater’s version of the Academy Awards) this month in New York City, and broadcast live on national television, she thanked her parents “for their unwillingness to put her on stimulant medication, which she believed led to her stunning success in musical theater.” In the aftermath, her comments […]
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Margaret Hamburg Addresses Biopharma’s Pressing Issues

Speaking at the 2014 New York BIO conference, FDA Commissioner, Dr. Margaret Hamburg, addressed the pressing issues affecting the biopharmaceutical industry and the FDA. Applied Clinical Trials’ Moe Alsumidaie relays Dr Hamburg’s the highlights of Dr. Hamburg’s presentation below.
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What Does ‘Off Label’ Mean in 2014?

by Tom Norton Years ago, while sitting in an Rx company lunch room, I was listening to one of the company’s top sales reps discuss the commercial progress a recently launched prescription was making. The rep said that the product was selling “OK” under its FDA approved, indicated therapeutic area. However, he quietly said, “It’s […]
Also posted in Biotech, Guest Blog, healthcare, Legal, Market Access, Marketing, pricing, Regulatory, Strategy | Tagged , , | 1 Comment

Supplier Audit Program Marks Progress

The Rx360 pharmaceutical supply chain consortium celebrated its first five years with an anniversary conference on June 5  in Washington, D.C., featuring key FDA officials and industry leaders. This collaborative effort to streamline and coordinate manufacturer audits of ingredient suppliers was launched in 2009 in response to the heparin adulteration crisis, which raised broad concerns […]
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Paying for the Future of Medicine

Is the hallmark of innovation higher drug prices? The three leading justifications for sticker-shocking drug prices in the US, from the biopharma perspective, are: 1) it costs a lot to bring a drug to market;* 2) drugs – even very expensive ones – are cheaper in the long run since they prevent complications, hospitalizations and […]
Also posted in Biotech, healthcare, leadership, Manufacturing, Market Access, pricing, R&D, Regulatory, Technology | Tagged , , , , , , | 1 Comment
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