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2018-03-01
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Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment; Guidance for Industry; Availability
Notices
D09002ee1bdc247a6
D09002ee1bdc24820
United States
Department of Health and Human Services
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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 guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in all phases of development of antiretroviral drugs and therapeutic biologic products for the treatment of HIV-1 infection.
80 FR 67761
https://www.govinfo.gov/app/details/FR-2015-11-03/2015-27935
2015-27935
fr03no15-55
4164-01-P
Docket No. FDA-2013-D-0589
https://www.govinfo.gov/app/details/FR-2015-11-03/2015-27935
https://www.govinfo.gov/content/pkg/FR-2015-11-03/html/2015-27935.htm
https://www.govinfo.gov/content/pkg/FR-2015-11-03/pdf/2015-27935.pdf
2 p.
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80 FR 67761
Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment; Guidance for Industry; Availability; Federal Register Vol. 80, Issue
NOTICE
2015-27935
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2013-D-0589
4164-01-P
2015-27935
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in all phases of development of antiretroviral drugs and therapeutic biologic products for the treatment of HIV-1 infection.
Submit either electronic or written comments on Agency guidances at any time.
Jeffrey Murray, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6360, Silver Spring, MD 20993-0002, 301- 796-1500.
Guidance:
Human Immunodeficiency Virus-1 InfectionDeveloping Antiretroviral Drugs for Treatment
,
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.fda.gov/regulatoryinformation/dockets/default.htm
http://www.regulations.gov
Federal Register
Vol. 80, no. 212
Office of the Federal Register, National Archives and Records Administration
2015-11-03
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629 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2015-11-03
P0b002ee198a25035
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr03no15
https://www.govinfo.gov/app/details/FR-2015-11-03
https://www.govinfo.gov/content/pkg/FR-2015-11-03/pdf/FR-2015-11-03.pdf
https://www.govinfo.gov/content/pkg/FR-2015-11-03/xml/FR-2015-11-03.xml
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