CDER announced a pilot program on established conditions. The pilot will provide an opportunity for a limited number of applicants to propose explicit ECs as part of an original NDA, ANDA, BLA or prior approval supplement (PAS). FDA will accept nine requests submitted before May 30, 2019. The concept of established conditions was described in a 2015 FDA draft guidance for industry and is further addressed in ICH’s May 2018 Q12 draft guideline on product lifecycle management. The announcement explains that FDA is “implementing this pilot program to gain experience receiving, assessing, and engaging with applicants regarding proposed ECs.” [See IPQ August 13, 2018 for more on the discussions and initiatives around EC implementation in the context of ICH Q12.]
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