James G. DIckinson

Most Recent Articles by James G. DIckinson

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venture this summer into regulating medical marketers' activities in social media, the industry reacted sharply to a draft guidance the agency issued in January

Let FDA top performers set pace, study says

Let FDA top performers set pace, study says

A Manhattan Institute analysis says that helping underperforming FDA drug review divisions match the output of high-performing divisions could cut development costs and speed approval of new treatments.

Did lawyers help write labeling rules?

Did lawyers help write labeling rules?

Nineteen Republicans on the House Energy and Commerce Committee want FDA commissioner Margaret Hamburg to explain the role the American Association for Justice (trial lawyers) played in drafting proposed changes to generic drug labeling.

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