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FDA's new policy accelerates the development of new excipients!

 Last Update: 2021-09-18
 Source: Internet
 Author: User

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Existing excipients can’t keep up with the progress of new drug research and development? FDA voluntary new excipients review check pilot program ( Novel Excipient Review Pilot Program , to accelerate the development of accessories! Recently, FDA Center for Drug Evaluation and Research (CDER) launched a voluntary pilot program to review the new materials (Pilot Program), designed to allow materials Manufacturing Before certain new excipients are used in pharmaceutical formulations, the FDA has obtained review

Possibility for manufacturers of new excipients to submit complete data packages within a given time frame

New excipients actively improve the overall potential of pharmacokinetic characteristics in terms of facilitating the development of new drugs

Interested excipient manufacturers should submit preliminary proposals to Novel-Excipient-Program@fda.

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