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2019-08-14
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Gastroparesis: Clinical Evaluation of Drugs for Treatment; Draft Guidance for Industry; Availability
Notices
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D09002ee1c12c849c
United States
Department of Health and Human Services
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United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Gastroparesis: Clinical Evaluation of Drugs for Treatment.'' This draft guidance is intended to provide the FDA's current thinking regarding clinical trial design and clinical endpoint assessments to support development of drugs for the treatment of diabetic and idiopathic gastroparesis. This draft guidance replaces the draft guidance for industry of the same name issued July 23, 2015.
84 FR 40423
https://www.govinfo.gov/app/details/FR-2019-08-14/2019-17463
2019-17463
fr14au19-66
4164-01-P
Docket No. FDA-2015-D-2479
https://www.govinfo.gov/app/details/FR-2019-08-14/2019-17463
https://www.govinfo.gov/content/pkg/FR-2019-08-14/html/2019-17463.htm
https://www.govinfo.gov/content/pkg/FR-2019-08-14/pdf/2019-17463.pdf
2 p.
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84 FR 40423
Gastroparesis: Clinical Evaluation of Drugs for Treatment; Draft Guidance for Industry; Availability; Federal Register Vol. 84, Issue
NOTICE
2019-17463
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2019-10-15
Docket No. FDA-2015-D-2479
4164-01-P
2019-17463
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Gastroparesis: Clinical Evaluation of Drugs for Treatment.'' This draft guidance is intended to provide the FDA's current thinking regarding clinical trial design and clinical endpoint assessments to support development of drugs for the treatment of diabetic and idiopathic gastroparesis. This draft guidance replaces the draft guidance for industry of the same name issued July 23, 2015.
Submit either electronic or written comments on the draft guidance by October 15, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Juli Tomaino, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5373, Silver Spring, MD 20993-0002, 301- 796-8812.
Guidance:
Gastroparesis: Clinical Evaluation of Drugs for Treatment
,
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 84, no. 157
Office of the Federal Register, National Archives and Records Administration
2019-08-14
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1377 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2019-08-14
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https://www.govinfo.gov/app/details/FR-2019-08-14
https://www.govinfo.gov/content/pkg/FR-2019-08-14/pdf/FR-2019-08-14.pdf
https://www.govinfo.gov/content/pkg/FR-2019-08-14/xml/FR-2019-08-14.xml
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