United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2017_register executive 2017-10-03 article Notices D09002ee1c7f0e82d D09002ee1c7f0e89a United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA." This draft guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit (or an applicant that has submitted) to FDA an abbreviated new drug application (ANDA) for a complex product. Specifically, this draft guidance provides information on requesting and conducting product development meetings, pre-submission meetings, and mid-review-cycle meetings with FDA. This draft guidance will assist applicants in generating and submitting a meeting request and the associated meeting package to FDA for complex products to be submitted under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and as contemplated in the commitments made by FDA in connection with the reauthorization of the Generic Drug User Fee Amendments for Fiscal Years (FYs) 2018-2022 (GDUFA II). 82 FR 46071 https://www.govinfo.gov/app/details/FR-2017-10-03/2017-21190 2017-21190 fr03oc17-64 4164-01-P Docket No. FDA-2017-D-5739 https://www.govinfo.gov/app/details/FR-2017-10-03/2017-21190 https://www.govinfo.gov/content/pkg/FR-2017-10-03/html/2017-21190.htm https://www.govinfo.gov/content/pkg/FR-2017-10-03/pdf/2017-21190.pdf 2 p. 46071 46072 82 FR 46071 Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Act; Draft Guidance for Industry; Availability; Federal Register Vol. 82, Issue NOTICE 2017-21190 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2017-12-04 Docket No. FDA-2017-D-5739 4164-01-P 2017-21190 Notice of availability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA." This draft guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit (or an applicant that has submitted) to FDA an abbreviated new drug application (ANDA) for a complex product. Specifically, this draft guidance provides information on requesting and conducting product development meetings, pre-submission meetings, and mid-review-cycle meetings with FDA. This draft guidance will assist applicants in generating and submitting a meeting request and the associated meeting package to FDA for complex products to be submitted under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and as contemplated in the commitments made by FDA in connection with the reauthorization of the Generic Drug User Fee Amendments for Fiscal Years (FYs) 2018-2022 (GDUFA II).

Submit either electronic or written comments on the draft guidance by December 4, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Elizabeth Giaquinto Friedman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002, 240-402-7930, elizabeth.giaquinto@fda.hhs.gov. Guidance: Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Act , elizabeth.giaquinto@fda.hhs.gov https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 82, no. 190 Office of the Federal Register, National Archives and Records Administration 2017-10-03 continuing daily deposited born digital 177 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2017-10-03 P0b002ee19713cfb9 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr03oc17 https://www.govinfo.gov/app/details/FR-2017-10-03 https://www.govinfo.gov/content/pkg/FR-2017-10-03/pdf/FR-2017-10-03.pdf https://www.govinfo.gov/content/pkg/FR-2017-10-03/xml/FR-2017-10-03.xml fdlp 45955 46121 DGPO 2017-10-03 2024-06-01 FR-2017-10-03 machine generated eng FR FR-2017-10-03 82 190