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2018-02-14
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Bacillus Calmette-Guerin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment; Draft Guidance for Industry; Availability
Notices
D09002ee1bdc055be
D09002ee1bdc05667
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
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United States Government Agency or Subagency
Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Bacillus Calmette-Guerin (BCG)--Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment.'' The purpose of this guidance is to assist sponsors in the development of drugs and biologics to treat patients with a high-risk form of bladder cancer. The alternative is radical cystectomy, a surgical procedure with significant morbidity and mortality. This guidance will help overcome some of the obstacles in conducting the studies needed to establish efficacy of drugs and biologics for these patients with an unmet medical need.
81 FR 81778
https://www.govinfo.gov/app/details/FR-2016-11-18/2016-27762
2016-27762
fr18no16-85
4164-01-P
Docket No. FDA-2016-D-3456
https://www.govinfo.gov/app/details/FR-2016-11-18/2016-27762
https://www.govinfo.gov/content/pkg/FR-2016-11-18/html/2016-27762.htm
https://www.govinfo.gov/content/pkg/FR-2016-11-18/pdf/2016-27762.pdf
2 p.
81778
81779
81 FR 81778
Bacillus Calmette-Guerin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment; Draft Guidance for Industry; Availability; Federal Register Vol. 81, Issue
NOTICE
2016-27762
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2016-D-3456
4164-01-P
2016-27762
Notice of availability.
Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Bacillus Calmette-Guerin (BCG)--Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment.'' The purpose of this guidance is to assist sponsors in the development of drugs and biologics to treat patients with a high-risk form of bladder cancer. The alternative is radical cystectomy, a surgical procedure with significant morbidity and mortality. This guidance will help overcome some of the obstacles in conducting the studies needed to establish efficacy of drugs and biologics for these patients with an unmet medical need.
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 February 16, 2017.
V. Ellen Maher, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2352, Silver Spring, MD 20993-0002, 301- 796-5017; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
Draft Guidance for Industry:
Bacillus CalmetteGuerinUnresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment
,
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.fda.gov/regulatoryinformation/dockets/default.htm
http://www.regulations.gov
Federal Register
Vol. 81, no. 223
Office of the Federal Register, National Archives and Records Administration
2016-11-18
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1471 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2016-11-18
P0b002ee1986804d6
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr18no16
https://www.govinfo.gov/app/details/FR-2016-11-18
https://www.govinfo.gov/content/pkg/FR-2016-11-18/pdf/FR-2016-11-18.pdf
https://www.govinfo.gov/content/pkg/FR-2016-11-18/xml/FR-2016-11-18.xml
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