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 2013_register executive 2013-08-27 article Notices D09002ee1c7fb1227 D09002ee1c7fb12c1 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United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers." This draft guidance clarifies stability testing recommendations for abbreviated new drug applications (ANDAs) by providing responses to public comments in a questions-and-answers format. This draft guidance addresses public comments regarding FDA's recommendation to generic drug manufacturers to follow International Conference on Hamonisation (ICH) stability guidances Q1A (R2) through Q1E. 78 FR 52931 https://www.govinfo.gov/app/details/FR-2013-08-27/2013-20893 2013-20893 fr27au13-61 4160-01-P Docket No. FDA-2012-D-0938 https://www.govinfo.gov/app/details/FR-2013-08-27/2013-20893 https://www.govinfo.gov/content/pkg/FR-2013-08-27/html/2013-20893.htm https://www.govinfo.gov/content/pkg/FR-2013-08-27/pdf/2013-20893.pdf 2 p. 52931 52932 78 FR 52931 Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products, Questions and Answers; Availability; Federal Register Vol. 78, Issue NOTICE 2013-20893 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2012-D-0938 4160-01-P 2013-20893 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers." This draft guidance clarifies stability testing recommendations for abbreviated new drug applications (ANDAs) by providing responses to public comments in a questions-and-answers format. This draft guidance addresses public comments regarding FDA's recommendation to generic drug manufacturers to follow International Conference on Hamonisation (ICH) stability guidances Q1A (R2) through Q1E.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 28, 2013. Radhika Rajagopalan, Center for Drug Evaluation and Research (HFD-640), Food and Drug Administration, 7500 Standish Pl., MPN2, Rm. 243, Rockville, MD 20855, 240-276-8546. Draft Guidance for Industry; Availability: Abbreviated New Drug Applications; Stability Testing of Drug Substances and Products, Questions and Answers , http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065005.htm http://www.regulations.gov Vol. 78, no. 166 Office of the Federal Register, National Archives and Records Administration 2013-08-27 continuing daily deposited born digital 200 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2013-08-27 P0b002ee186073330 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr27au13 https://www.govinfo.gov/app/details/FR-2013-08-27 https://www.govinfo.gov/content/pkg/FR-2013-08-27/pdf/FR-2013-08-27.pdf https://www.govinfo.gov/content/pkg/FR-2013-08-27/xml/FR-2013-08-27.xml fdlp 52827 53015 DGPO 2013-08-27 2024-06-03 FR-2013-08-27 machine generated eng FR FR-2013-08-27 78 166