James G. DIckinson

Most Recent Articles by James G. DIckinson

FDA and off-label uses: a balancing act

FDA and off-label uses: a balancing act

FDA's current re-examination of its off-label promotion policies in light of the First Amendment is a delicate balancing act between its rock-solid traditional enforcement posture and a diverse new electronic communications environment.

Washington Insider: When FDA overstates its case

Washington Insider: When FDA overstates its case

What happens when it's the FDA—not a medical marketer—that is doing the overstating?

House bill would speed approval once EU OKs same product

House bill would speed approval once EU OKs same product

The Speeding Access to Already Approved Pharmaceuticals Act of 2014 would require FDA to expedite the review of pharmaceuticals that are already approved by the European Union

FDA gets treatment guidance from patient advocates

FDA gets treatment guidance from patient advocates

Parent Project Muscular Dystrophy (PPMD) and allied stakeholders recently gave FDA the first patient advocacy-initiated guidance for a rare disease to help accelerate development and review of potential therapies for Duchenne muscular dystrophy.

Industry resists FDA's social-media stance

Industry resists FDA's social-media stance

Months before FDA's expected main venture this summer into regulating medical marketers' activities in social media, the industry reacted sharply to a draft guidance the agency issued in January

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