Are you planning to send a submission to the FDA?
Will this submission contain study data?
If the answer to these 2 questions has been yes, this brochure may be of your interest, due to the implementation by the FDA of the Technical Rejection Criteria (TRC) for Study Data by CDER and CBER.
Have a look at this brochure for an overview in detail:
Download here:
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As a company committed to sustainability, we follow the UN’s 2030 Agenda and its Sustainable Development Goals.
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SDGs
As a company committed to sustainability, we follow the UN’s 2030 Agenda and its Sustainable Development Goals.
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