Category Archives: FDA

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

FDA Takes First Amendment Issues "Seriously"

Several legal cases have challenged the Food and Drug Administration’s approach to regulating industry communications about medical products, and agency officials now are acknowledging the importance of addressing these developments head-on. In the wake of U.S. v. Caronia and IMS v. Sorrell, the spotlight is on speech-related activity, including product labeling and advertising and promotion […]
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US Pharmacopeia Head Wants Fresh Outlook

In anticipation of the 200th anniversary of the United States Pharmacopeia (USP) in 2020, the organization’s new leadership is taking a fresh look at its role in setting standards for pharmaceutical development and production and how that has been altered by new regulatory policies and industry globalization. USP chief executive officer Ron Piervincenzi is consulting […]
Also posted in Regulatory, Safety | Tagged , , , | Leave a comment
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