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The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products.
08-08 December 2022
In an original CTA or IND for a FIH trial, companies are primarily required to provide information on the safety and quality of the drug (or biologic) to support clinical studies. These summaries are expected in regulatory submissions and are particu
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