One Step Forward In PDUFA Reauthorization

One Step Forward In PDUFA Reauthorization

09.01.11 | By Kate Connors

Today, the FDA published the PDUFA-V performance goals letter, detailing the agreement that resulted from many months of technical negotiations between the biopharmaceutical industry and FDA, with unprecedented input from a variety of stakeholders, including patients and medical provider groups.

This represents a big step forward in our efforts to assure that FDA has the necessary resources to strengthen its review capabilities (see our statement here).

However, let's not forget that we still have work to do. Now, we must move forward, working with all stakeholders, including Congress and the Administration.

We must turn our attention to expedient approval of a clean PDUFA bill so that the FDA can continue to review new medicines in a timely and predictable manner, bolstering America's health care system for the benefit of patients.

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