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2019-07-12
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Establishing Effectiveness and Safety for Hormonal Drug Products Intended To Prevent Pregnancy; Draft Guidance for Industry; Availability
Notices
D09002ee1c12d49ef
D09002ee1c12d4a6d
United States
Department of Health and Human Services
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United States Government Agency or Subagency
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy.'' This draft guidance describes FDA's current thinking on key design considerations for these trials to help facilitate development of new and improved hormonal drug products for contraception. This draft guidance does not address development of contraceptive devices for this indication.
84 FR 33268
https://www.govinfo.gov/app/details/FR-2019-07-12/2019-14855
2019-14855
fr12jy19-79
4164-01-P
Docket No. FDA-2019-D-2153
https://www.govinfo.gov/app/details/FR-2019-07-12/2019-14855
https://www.govinfo.gov/content/pkg/FR-2019-07-12/html/2019-14855.htm
https://www.govinfo.gov/content/pkg/FR-2019-07-12/pdf/2019-14855.pdf
2 p.
33268
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84 FR 33268
Establishing Effectiveness and Safety for Hormonal Drug Products Intended To Prevent Pregnancy; Draft Guidance for Industry; Availability; Federal Register Vol. 84, Issue
NOTICE
2019-14855
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2019-09-10
Docket No. FDA-2019-D-2153
4164-01-P
2019-14855
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy.'' This draft guidance describes FDA's current thinking on key design considerations for these trials to help facilitate development of new and improved hormonal drug products for contraception. This draft guidance does not address development of contraceptive devices for this indication.
Submit either electronic or written comments on the draft guidance by September 10, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Jennifer Mercier, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5390, Silver Spring, MD 20993-0002, 301- 796-0957.
Guidance:
Establishing Effectiveness and Safety for Hormonal Drug Products Intended To Prevent Pregnancy
,
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 84, no. 134
Office of the Federal Register, National Archives and Records Administration
2019-07-12
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536 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2019-07-12
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0042-1219
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https://www.govinfo.gov/app/details/FR-2019-07-12
https://www.govinfo.gov/content/pkg/FR-2019-07-12/pdf/FR-2019-07-12.pdf
https://www.govinfo.gov/content/pkg/FR-2019-07-12/xml/FR-2019-07-12.xml
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FR-2019-07-12
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