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Scientific advice is the provision of advice to a company by the European Medicines Agency on the appropriate tests and studies required in the development of a medicine or on the quality of a medi
A New Chemical Entity (NCE) is a compound, without any precedent among the regulated and approved drug products.
A NDA is the final step formally taken by a drug sponsor, wherein it applies to the Food and Drug Administration (FDA) for the approval required to market a new drug in the U.S.
A TPP is a format for a summary of a drug development program described in terms of labeling concepts.
Protocol assistance is the special form of scientific advice available for companies developing designated orphan medicines for rare diseases.