FDA is announcing pilot program..

by compinsprod

 

FDA is announcing the opportunity for a limited number of applicants to participate in an Established Conditions Pilot Program to propose explicit established conditions (ECs) as part of an original new drug application (NDA), abbreviated new drug application (ANDA), biologics license application (BLA), or as a prior approval supplement (PAS) to any of these.

Please click on the link below to read the entire article posted on the Federal Register website.

https://www.federalregister.gov/documents/2019/02/15/2019-02364/established-conditions-pilot-program?utm_campaign=SBIA%3A%20Established%20Conditions%20Pilot%20Program&utm_medium=email&utm_source=Eloqua

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