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FDA, stakeholders highlight details in PDUFA VI

August 15, 2016 7:00 AM UTC

At a public meeting on PDUFA VI, FDA and stakeholders said the agency must make good on its proposals to recruit, hire and retain qualified scientific and medical personnel in order to successfully implement PDUFA VI's other proposals.

"Having a shortfall in the Office of New Drugs of 200 or more people is not just an OND problem; it's not just a CDER problem," said BIO SVP of Science Policy Kay Holcombe, referring to FDA's Center for Drug Evaluation and Research. "It's a public health problem, and we need to solve this problem." ...