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 2008_register executive 2010-09-23 article Rules and Regulations D09002ee1c80881e0 D09002ee1c80882bb 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 amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND). In addition, elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry: CGMP for Phase 1 Investigational Drugs" dated November 2007 (the companion guidance). This guidance document sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action will also streamline and promote the drug development process. 73 FR 40453 https://www.govinfo.gov/app/details/FR-2008-07-15/E8-16011 E8-16011 fr15jy08-1 4160-01-S Docket No. FDA-2005-N-0170 https://www.govinfo.gov/app/details/FR-2008-07-15/E8-16011 https://www.govinfo.gov/content/pkg/FR-2008-07-15/html/E8-16011.htm https://www.govinfo.gov/content/pkg/FR-2008-07-15/pdf/E8-16011.pdf 11 p. 40453 40463 73 FR 40453 Title 21 Part 210 21 CFR Part 210 Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials; Federal Register Vol. 73, Issue RULE E8-16011 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2008-09-15 Docket No. FDA-2005-N-0170 4160-01-S E8-16011 Final rule.

The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND). In addition, elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry: CGMP for Phase 1 Investigational Drugs" dated November 2007 (the companion guidance). This guidance document sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action will also streamline and promote the drug development process.

This rule is effective September 15, 2008. Monica Caphart, Center for Drug Evaluation and Research (HFD-320), Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-3248, or Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials, http://www.fda.gov/cder/warn/2003/02-hfd-45-0303.pdf www.bls.gov Vol. 73, no. 136 Office of the Federal Register, National Archives and Records Administration 2008-07-15 continuing daily deposited born digital 272 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2008-07-15 P0b002ee1809bec07 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr15jy08 https://www.govinfo.gov/app/details/FR-2008-07-15 https://www.govinfo.gov/content/pkg/FR-2008-07-15/pdf/FR-2008-07-15.pdf https://www.govinfo.gov/content/pkg/FR-2008-07-15/xml/FR-2008-07-15.xml fdlp 40453 40713 DGPO 2010-09-23 2024-06-05 FR-2008-07-15 machine generated eng FR FR-2008-07-15 73 136