Immuno-Oncology’s Revolutionary Impact – On US FDA
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.
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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.
A National Academies of Medicine forum on the new, hyper-fast development path for oncology drugs included a surprising amount of discussion about drug pricing; this wasn’t a setting for attacks on drug prices, but instead a recognition that coverage and payment models may make it hard to rely on post-marketing work to support streamlined pre-market development programs.