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Some critics are wondering whether the FDA has the time and people the agency needs to process the additional data it is requesting in its proposed rule on in vivo bioequivalence (BE) data submitted in abbreviated new drug applications (ANDAs).
Critics of the FDA’s proposed rule on in vivo bioequivalence (BE) data are wondering whether the agency can find the additional time and personnel needed to comprehensively review drugmakers’ BE data submitted in abbreviated new drug applications (ANDAs).
Communications that Amylin Pharmaceuticals made about its diabetes drug candidate Symlin will fall under the scrutiny of the Securities and Exchange Commission (SEC) under an informal inquiry, the company announced last month.