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
2010_register
executive
2010-10-14
article
Draft Guidance for Industry on Investigational New Drug Applications-Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Availability
Notices
D09002ee1bdd1587b
D09002ee1bdd1590a
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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Investigational New Drug Applications (INDs)--Determining Whether Human Research Studies Can Be Conducted Without an IND.'' This draft guidance is intended to assist clinical investigators, sponsors, and sponsor-investigators in determining whether planned human research studies must be conducted under an investigational new drug application (IND). The guidance describes the basic criteria for when an IND is required, describes specific situations in which an IND is not required, and discusses a range of issues that, in FDA's experience, have been the source of confusion or misperceptions about the application of the IND requirements.
75 FR 63189
https://www.govinfo.gov/app/details/FR-2010-10-14/2010-25851
2010-25851
FR14OC10-82
4160-01-P
Docket No. FDA-2010-D-0503
https://www.govinfo.gov/app/details/FR-2010-10-14/2010-25851
https://www.govinfo.gov/content/pkg/FR-2010-10-14/html/2010-25851.htm
https://www.govinfo.gov/content/pkg/FR-2010-10-14/pdf/2010-25851.pdf
3 p.
63189
63191
75 FR 63189
Draft Guidance for Industry on Investigational New Drug Applications-Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Availability; Federal Register Vol. 75, Issue
NOTICE
2010-25851
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2010-D-0503
4160-01-P
2010-25851
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Investigational New Drug Applications (INDs)--Determining Whether Human Research Studies Can Be Conducted Without an IND.'' This draft guidance is intended to assist clinical investigators, sponsors, and sponsor-investigators in determining whether planned human research studies must be conducted under an investigational new drug application (IND). The guidance describes the basic criteria for when an IND is required, describes specific situations in which an IND is not required, and discusses a range of issues that, in FDA's experience, have been the source of confusion or misperceptions about the application of the IND requirements.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comments 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 January 12, 2011. Submit either electronic or written comments concerning proposed collection of information by December 13, 2010.
Sandy Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4204, Silver Spring, MD 20993-0002, 301-796-1077, or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827- 6210.
Draft Guidance for Industry; Availability, etc.:
Investigational New Drug Applications; Determining Whether Human Research Studies, etc.
,
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.regulations.gov
Federal Register
Vol. 75, no. 198
Office of the Federal Register, National Archives and Records Administration
2010-10-14
continuing
daily
deposited
born digital
350 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2010-10-14
P0b002ee180b0b113
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:FR14OC10
https://www.govinfo.gov/app/details/FR-2010-10-14
https://www.govinfo.gov/content/pkg/FR-2010-10-14/pdf/FR-2010-10-14.pdf
https://www.govinfo.gov/content/pkg/FR-2010-10-14/xml/FR-2010-10-14.xml
fdlp
63039
63377
DGPO
2010-10-14
2023-05-01
FR-2010-10-14
machine generated
eng
FR
FR-2010-10-14
75
198