Complex Generics: Pre-Competitive Research Collaborations To Get US FDA Funding Boost
Center for Research on Complex Generics will be similar to the Critical Path Institute; training sessions for industry could begin in January.
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US FDA should create a policy to help save troubled studies, because failure can kill generic development programs, Lachman Consultants’ Michelle Ryder suggests.
US FDA and complex generic sponsors need a way to talk about reference product and other changes once the pre-submission meetings pathway is exhausted.