D1S04-Fields-v1.2-FINAL.pdf

1、Controlled CorrespondenceMinimizing Rejections,Maximizing ResultsLCDR Marcia Fields,PharmDRegulatory OfficerLieutenant Commander,US Public Health ServiceOffice of Regulatory Affairs(ORO),Immediate Office(IO),Office of Generic Drugs(OGD)CDER US FDAGeneric Drugs Forum-April 22,2026 www.fda.gov2Learnin

2、g Objectives Define and categorize controlled correspondences Understand submission requirements Avoid Common Mistakes Provide Resourceswww.fda.gov3Controlled Correspondence DefinedTwo Types of Controlled Correspondences:Level 1(FDA responds to 90%within 60 calendar days of the date of submission)Le

3、vel 2(FDA responds to 90%within 120 calendar days of the date of submission)www.fda.gov4Level 1 Controlled Correspondence The GDUFA III commitment letter defines level 1 controlled correspondence as correspondence submitted to the Agency,by or on behalf of a generic drug manufacturer or related indu

4、stry:1.Requesting information on a specific element of generic drug product development:a.Before ANDA submission;b.After a Product-Specific Guidance(PSG)Teleconference if a prospective applicant or applicant seeks further feedback from FDA;c.After issuance of a complete response letter(CRL)or tentat

5、ive approval;d.After ANDA approval2.Concerning post approval submission requirements that are not covered by Center for Drug Evaluation and Research(CDER)post approval changes guidance and are not specific to an ANDA.www.fda.gov5Level 2 Controlled Correspondence The GDUFA III commitment letter defin

6、es level 2 controlled correspondence as correspondence that meets the definition of level 1 controlled correspondence and:1.Involves evaluation of clinical content;2.Requests a Covered Product Authorization and review of bioequivalence(BE)protocols for development and testing that involves human cli