Model-Informed Drug Development: A Risk Firms, Regulators Need To Embrace
Modeling can better inform candidate and dose selection, and support novel endpoints, labeling and postmarketing safety, even though it means stepping off the beaten path for drug development, participants say at US FDA's inaugural workshop on model-informed drug development under PDUFA VI.
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Meeting requests from sponsors that focus on safety prediction will also be prioritized.
Unprecedented wave of cancer immunotherapies is in some ways a mirror image of AIDS crisis as FDA explores new tools to accelerate drug development, including modeling techniques and statistical approaches to efficacy. It's an effort to encourage a regulatory revolution in response to a massive number of products in development as opposed to the AIDS-era effort to get products studied.
The latest drug development news and highlights from our FDA Performance Tracker.