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 2023_register executive 2023-10-12 article Notices D09002ee1c7975fc2 D09002ee1c7976173 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Government Agency or Subagency The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Quality Considerations for Topical Ophthalmic Drug Products." This draft guidance discusses certain quality considerations for ophthalmic drug products (i.e., solutions, suspensions, emulsions, gels, ointments, and creams) intended for topical delivery in and around the eye. Specifically, this draft guidance discusses approaches to evaluating visible particulate matter, extractables and leachables, and impurities and degradation products; use of in vitro drug release/dissolution testing as an optional quality control strategy for certain ophthalmic dosage forms; recommendations for design and delivery and dispensing features of container closure systems; and recommendations for stability studies. The draft guidance applies to ophthalmic drug products approved under new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), as well as to over-the-counter (OTC) monograph drugs. 88 FR 70997 https://www.govinfo.gov/app/details/FR-2023-10-13/2023-22650 2023-22650 fr13oc23-75 4164-01-P Docket No. FDA-2023-D-4177 https://www.govinfo.gov/app/details/FR-2023-10-13/2023-22650 https://www.govinfo.gov/content/pkg/FR-2023-10-13/html/2023-22650.htm https://www.govinfo.gov/content/pkg/FR-2023-10-13/pdf/2023-22650.pdf 2 p. 70997 70998 88 FR 70997 Quality Considerations for Topical Ophthalmic Drug Products; Draft Guidance for Industry; Availability; Federal Register Vol. 88, Issue NOTICE 2023-22650 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2023-12-12 Docket No. FDA-2023-D-4177 4164-01-P 2023-22650 Notice of availability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Quality Considerations for Topical Ophthalmic Drug Products." This draft guidance discusses certain quality considerations for ophthalmic drug products (i.e., solutions, suspensions, emulsions, gels, ointments, and creams) intended for topical delivery in and around the eye. Specifically, this draft guidance discusses approaches to evaluating visible particulate matter, extractables and leachables, and impurities and degradation products; use of in vitro drug release/dissolution testing as an optional quality control strategy for certain ophthalmic dosage forms; recommendations for design and delivery and dispensing features of container closure systems; and recommendations for stability studies. The draft guidance applies to ophthalmic drug products approved under new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), as well as to over-the-counter (OTC) monograph drugs.

Submit either electronic or written comments on the draft guidance by December 12, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Ranjani Prabhakara, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 6648, Silver Spring, MD 20993-0002, 240- 402-4652. Guidance: Quality Considerations for Topical Ophthalmic Drug Products, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs https://www.fda.gov/regulatory-information/search-fda-guidance-documents https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 88, no. 197 Office of the Federal Register, National Archives and Records Administration 2023-10-13 continuing daily deposited born digital 394 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2023-10-13 P0b002ee1c178ee92 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr13oc23 https://www.govinfo.gov/app/details/FR-2023-10-13 https://www.govinfo.gov/content/pkg/FR-2023-10-13/pdf/FR-2023-10-13.pdf https://www.govinfo.gov/content/pkg/FR-2023-10-13/xml/FR-2023-10-13.xml fdlp 70885 71271 DGPO 2023-10-12 2024-05-28 FR-2023-10-13 machine generated eng FR FR-2023-10-13 88 197