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2017-10-13
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``Determining Whether To Submit an Abbreviated New Drug Application or a 505(b)(2) Application;'' Draft Guidance for Industry; Availability
Notices
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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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Determining Whether to Submit an ANDA or a 505(b)(2) Application.'' This guidance is intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) is appropriate for the submission of a marketing application to FDA.
82 FR 47749
https://www.govinfo.gov/app/details/FR-2017-10-13/2017-22196
2017-22196
fr13oc17-80
4164-01-P
Docket No. FDA-2017-D-5974
https://www.govinfo.gov/app/details/FR-2017-10-13/2017-22196
https://www.govinfo.gov/content/pkg/FR-2017-10-13/html/2017-22196.htm
https://www.govinfo.gov/content/pkg/FR-2017-10-13/pdf/2017-22196.pdf
2 p.
47749
47750
82 FR 47749
``Determining Whether To Submit an Abbreviated New Drug Application or a 505(b)(2) Application;'' Draft Guidance for Industry; Availability; Federal Register Vol. 82, Issue
NOTICE
2017-22196
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2017-12-12
Docket No. FDA-2017-D-5974
4164-01-P
2017-22196
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Determining Whether to Submit an ANDA or a 505(b)(2) Application.'' This guidance is intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) is appropriate for the submission of a marketing application to FDA.
Submit either electronic or written comments on the draft guidance by December 12, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Elizabeth Giaquinto Friedman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Rm. 1670, Silver Spring, MD 20993, 240-402-7930, elizabeth.giaquinto@fda.hhs.gov.
Guidance:
Determining Whether to Submit an Abbreviated New Drug Application or a 505(b)(2) Application
,
elizabeth.giaquinto@fda.hhs.gov
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.regulations.gov
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
Federal Register
Vol. 82, no. 197
Office of the Federal Register, National Archives and Records Administration
2017-10-13
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351 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2017-10-13
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https://www.govinfo.gov/app/details/FR-2017-10-13
https://www.govinfo.gov/content/pkg/FR-2017-10-13/pdf/FR-2017-10-13.pdf
https://www.govinfo.gov/content/pkg/FR-2017-10-13/xml/FR-2017-10-13.xml
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2017-10-13
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