Established Conditions Pilot Program

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.  

Last year, the FDA published a draft guidance for industry titled, “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.” This guidance, developed under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), provides a risk-based approach to regulatory oversight of post-approval manufacturing changes. The framework in this guidance provides a mechanism for applicants to gain agreement with the agency on the ECs necessary to ensure product quality, and to facilitate post-approval changes to those established conditions with a level of regulatory oversight commensurate with the applicant’s knowledge about their product and manufacturing process.

The objectives of this pilot program are to gain practical experience in:

• assessing proposed ECs (i.e., explicit ECs); 
• engaging with applicants during the review cycle to refine proposed ECs; 
• ensuring assessment decisions are made without negatively impacting the ability to meet user fee timeframes; and
• identifying agreed-upon ECs at the time of approval.  

Parties who have an interest in participating in this Established Conditions Pilot Program and who plan to propose explicit ECs in an upcoming marketing application should submit a written request to the CDER-OPQ-Inquiries@fda.hhs.gov mailbox.  Requests should include information outlined in the Federal Register notice.  FDA will accept nine requests submitted before May 30, 2019 from applicants intending to submit NDAs, ANDAs, or BLAs, either original applications or prior approval supplements, with proposed ECs.  The submission of the application should be planned for receipt by FDA no later than July 1, 2019.