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# Established Conditions Pilot Program
- URL: https://www.fdaweb.com/established-conditions-pilot-program/
- Published: 2019-02-14T12:00:00.000Z
- Updated: 2026-09-15T01:04:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143386

CDER is soliciting applications for an Established Conditions pilot program to propose explicit established conditions (ECs) as part of an NDA, ANDA, BLA, or prior approval supplement to any of those three. A *Federal Register* [notice](https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-02364.pdf?ref=fdaweb.com) says the concept of ECs was first described in a 5/2015 FDA draft guidance and has been further discussed in an International Council for Harmonization 5/2018 draft guidance. FDA says it is implementing the pilot program “to gain experience receiving, assessing, and engaging with applicants regarding proposed ECs (that is, explicit ECs).”

The agency says it will accept nine requests submitted before 5/30 from applicants intending to submit any of the specified applications or supplements with proposed ECs.

The notice says the pilot’s objectives are to gain practical experience in: 

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