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 2009_register executive 2009-08-13 article Part II Rules and Regulations D09002ee1c8042fe8 D09002ee1c80430df 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 its regulations on access to investigational new drugs for the treatment of patients. The final rule clarifies existing regulations and adds new types of expanded access for treatment use. Under the final rule, expanded access to investigational drugs for treatment use is available to individual patients, including in emergencies; intermediate-size patient populations; and larger populations under a treatment protocol or treatment investigational new drug application (IND). The final rule is intended to improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who lack other therapeutic options and who may benefit from such therapies. Elsewhere in this issue of the Federal Register, FDA is publishing the final rule on Charging for Investigational Drugs Under an Investigational New Drug Application which clarifies the circumstances in which charging for an investigational drug in a clinical trial is appropriate, sets forth criteria for charging for an investigational drug for the different types of expanded access for treatment use described in this final rule, and clarifies what costs can be recovered for an investigational drug. 74 FR 40900 https://www.govinfo.gov/app/details/FR-2009-08-13/E9-19005 E9-19005 FR13AU09-14 RIN 0910-AF14 4160-01-S Docket No. FDA-2006-N-0238 https://www.govinfo.gov/app/details/FR-2009-08-13/E9-19005 https://www.govinfo.gov/content/pkg/FR-2009-08-13/html/E9-19005.htm https://www.govinfo.gov/content/pkg/FR-2009-08-13/pdf/E9-19005.pdf Drugs Exports Imports Investigations Labeling Medical Research Reporting and Recordkeeping Requirements Safety Administrative Practice and Procedure 46 p. 40900 40945 74 FR 40900 Title 21 Part 312 21 CFR Part 312 Title 21 Part 316 21 CFR Part 316 RIN 0910-AF14 Expanded Access to Investigational Drugs for Treatment Use; Federal Register Vol. 74, Issue RULE E9-19005 II DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2009-10-13 Docket No. FDA-2006-N-0238 4160-01-S E9-19005 Final rule.

The Food and Drug Administration (FDA) is amending its regulations on access to investigational new drugs for the treatment of patients. The final rule clarifies existing regulations and adds new types of expanded access for treatment use. Under the final rule, expanded access to investigational drugs for treatment use is available to individual patients, including in emergencies; intermediate-size patient populations; and larger populations under a treatment protocol or treatment investigational new drug application (IND). The final rule is intended to improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who lack other therapeutic options and who may benefit from such therapies. Elsewhere in this issue of the Federal Register, FDA is publishing the final rule on Charging for Investigational Drugs Under an Investigational New Drug Application which clarifies the circumstances in which charging for an investigational drug in a clinical trial is appropriate, sets forth criteria for charging for an investigational drug for the different types of expanded access for treatment use described in this final rule, and clarifies what costs can be recovered for an investigational drug.

This rule is effective October 13, 2009. Colleen L. Locicero, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4200, Silver Spring, MD 20993-0002, 301-796-2270; or Drugs Exports Imports Investigations Labeling Medical Research Reporting and Recordkeeping Requirements Safety Administrative Practice and Procedure Expanded Access to Investigational Drugs for Treatment Use , druginfo@fda.hhs.gov emergency.operations@fda.hhs.gov ocod@fda.hhs.gov ClinicalTrials.gov http://swz.salary.com/salarywizard/layoutscripts/swzl_newsearch.asp http://www.bls.gov/news.release/ecec.toc.htm http://www.clinicaltrials.gov http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/default.htm http://www.fda.gov/oashi/home.html Vol. 74, no. 155 Office of the Federal Register, National Archives and Records Administration 2009-08-13 continuing daily deposited born digital 319 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2009-08-13 P0b002ee18001e450 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:FR13AU09 https://www.govinfo.gov/app/details/FR-2009-08-13 https://www.govinfo.gov/content/pkg/FR-2009-08-13/pdf/FR-2009-08-13.pdf https://www.govinfo.gov/content/pkg/FR-2009-08-13/xml/FR-2009-08-13.xml fdlp 40719 41031 DGPO 2009-08-13 2024-06-04 FR-2009-08-13 machine generated eng FR FR-2009-08-13 74 155