How can we best advance the science of patient input to improve the efficiency of the drug development and regulatory review process?

Marc Boutin on PDUFA

Submitted by Emily on Tue, 11/11/2014 - 09:30

An astute marketer will tell you that success of any product is dependent on the wants and needs of the end user. In health care, we need a similar mindset. By collaborating with patients early in drug development, there is an opportunity to improve the success rates in the preclinical stage of the development, which could ultimately accelerate the delivery of new treatments to patients and enhance patient adherence to their treatment plans. The end result will be a win for all stakeholders.

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Robert Metcalf on PFDD

Submitted by Emily on Tue, 11/11/2014 - 10:20

The most recent reauthorization of the Prescription Drug User Fee Act (PDUFA) included new efforts by the Food and Drug Administration (FDA) to enable patients and patient groups to become actively involved in FDA evaluations of new medicines. Two programs in particular--the P...

Source: PHRMA - November 11, 2014 Category: Pharmaceuticals Authors: Emily Source Type: news