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2019-02-05
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Fiscal Year 2019 Generic Drug Regulatory Science Initiatives; Public Workshop; Request for Comments
Notices
D09002ee1bdb7c0f2
D09002ee1bdb7c1cb
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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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``FY 2019 Generic Drug Regulatory Science Initiatives.'' The purpose of the public workshop is to provide an overview of the status of regulatory science initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from a variety of stakeholders--industry, academia, patient advocates, professional societies, and other interested parties--as it fulfills its commitment under the Generic Drug User Fee Amendments of 2017 (GDUFA II) to develop an annual list of regulatory science initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its fiscal year (FY) 2020 regulatory science initiatives.
84 FR 1743
https://www.govinfo.gov/app/details/FR-2019-02-05/2019-01067
2019-01067
fr05fe19-86
4164-01-P
Docket No. FDA-2017-N-6644
https://www.govinfo.gov/app/details/FR-2019-02-05/2019-01067
https://www.govinfo.gov/content/pkg/FR-2019-02-05/html/2019-01067.htm
https://www.govinfo.gov/content/pkg/FR-2019-02-05/pdf/2019-01067.pdf
3 p.
1743
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84 FR 1743
Fiscal Year 2019 Generic Drug Regulatory Science Initiatives; Public Workshop; Request for Comments; Federal Register Vol. 84, Issue
NOTICE
2019-01067
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2019-06-01
Docket No. FDA-2017-N-6644
4164-01-P
2019-01067
Notice of public workshop; request for comments.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``FY 2019 Generic Drug Regulatory Science Initiatives.'' The purpose of the public workshop is to provide an overview of the status of regulatory science initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from a variety of stakeholders--industry, academia, patient advocates, professional societies, and other interested parties--as it fulfills its commitment under the Generic Drug User Fee Amendments of 2017 (GDUFA II) to develop an annual list of regulatory science initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its fiscal year (FY) 2020 regulatory science initiatives.
The public workshop will be held on May 1, 2019, from 8:30 a.m. to 4:30 p.m. Submit either electronic or written comments on this public workshop by June 1, 2019. See the SUPPLEMENTARY INFORMATION section for registration date and information.
Stephanie Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 3742, Silver Spring, MD 20993, 240-402- 7960, Stephanie.Choi@fda.hhs.gov; or Robert Lionberger, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4722, Silver Spring, MD 20993, 240-402- 7957, Robert.Lionberger@fda.hhs.gov.
Meetings:
Fiscal Year 2019 Generic Drug Regulatory Science Initiatives
,
GDUFARegulatoryScience@fda.hhs.gov
Robert.Lionberger@fda.hhs.gov
Stephanie.Choi@fda.hhs.gov
https://collaboration.fda.gov/common/help/en/support/meeting_test.htm
https://collaboration.fda.gov/gdufa2019/
https://www.adobe.com/go/connectpro_overview
https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm
https://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/UCM626329.pdf
https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.pdf
https://www.fda.gov/gdufaregscience
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 84, no. 24
Office of the Federal Register, National Archives and Records Administration
2019-02-05
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Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
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