Search Results for Patient-Centered Drug Development

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How can FDA be Improved? Patient Groups Offer Ideas By Alexander Gaffney, RAC - Published 10 December 2014

More than a dozen patient groups and trade associations are offering their advice to the US Food and Drug Administration (FDA) on ways the agency can improve its regulatory and administrative processes to take into account the views and expertise of patients and their advocates.

Categories: News, US, FDA

Tags: FDASIA, Patients, Patient Groups, Patient-Centered Drug Development, FDASIA Section 917, Recommendations for FDA

FDA Wants Input on Patient-Developed DMD Guidance By Alexander Gaffney, RAC - Published 03 September 2014

The US Food and Drug Administration (FDA) is calling for public comment on a new draft guidance document developed by patient advocates and intended to accelerate the development of therapies to treat Duchenne Muscular Dystrophy (DMD).

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Orphan products

Tags: DMD, Draft Guidance, PPMD, DMD Guidance, Patient-Centered Drug Development

New Patient-Focused Drug Development Meeting to Concentrate on Neurologic Disorders By Alexander Gaffney, RAC - Published 24 April 2014

Categories: US, FDA, CDER

Tags: Patient-Centered Drug Development, FDASIA, Latest News, patients