Industry Seeks Bigger Role In Tackling Regulatory Science
The Biotechnology Industry Organization is pushing for a place at the table in shaping regulatory science.
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FDA Wants To Help You Develop Drugs
The agency’s report on innovative drug approvals in FY 2012 documents the successful performance metrics for the 35 novel medicines, including first-cycle review rates and on-time user fee targets, but it notes that a larger problem lies in early stages of drug discovery and development – and it thinks it can help.
Regulatory Science Next To Be Outsourced?
CDER report calls for broader partnerships with outside bodies in regulatory science.
Sentinel Initiative Needs Better Defined Goals, Outside Review Concludes
The Pharmacovigilance Review Subcommittee of FDA's Science Board reports a lack of clarity within CDER over just what purpose the drug safety program is supposed to serve.