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2013-03-30
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Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product Sponsors or Applicants; Availability
Notices
D09002ee1bdca6bdf
D09002ee1bdca6c64
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
originator
org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.'' This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidance assists sponsors and applicants in generating and submitting a meeting request and the associated meeting package to FDA for biosimilar biological products.
78 FR 19492
https://www.govinfo.gov/app/details/FR-2013-04-01/2013-07445
2013-07445
fr01ap13-47
4160-01-P
Docket No. FDA-2013-D-0286
https://www.govinfo.gov/app/details/FR-2013-04-01/2013-07445
https://www.govinfo.gov/content/pkg/FR-2013-04-01/html/2013-07445.htm
https://www.govinfo.gov/content/pkg/FR-2013-04-01/pdf/2013-07445.pdf
4 p.
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78 FR 19492
Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product Sponsors or Applicants; Availability; Federal Register Vol. 78, Issue
NOTICE
2013-07445
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2013-D-0286
4160-01-P
2013-07445
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.'' This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidance assists sponsors and applicants in generating and submitting a meeting request and the associated meeting package to FDA for biosimilar biological products.
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 May 31, 2013. Submit either electronic or written comments concerning the proposed collection of information by May 31, 2013.
Neel Patel, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6483, Silver Spring, MD 20993-0002, 301-796-0970; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6210.
Draft Guidance for Industry; Availability:
Formal Meetings Between FDA and Biosimilar Biological Product Sponsors or Applicants
,
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM281991.pdf
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.regulations.gov
Federal Register
Vol. 78, no. 62
Office of the Federal Register, National Archives and Records Administration
2013-04-01
continuing
daily
deposited
born digital
201 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2013-04-01
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https://www.govinfo.gov/app/details/FR-2013-04-01
https://www.govinfo.gov/content/pkg/FR-2013-04-01/pdf/FR-2013-04-01.pdf
https://www.govinfo.gov/content/pkg/FR-2013-04-01/xml/FR-2013-04-01.xml
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2013-03-30
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FR-2013-04-01
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FR-2013-04-01
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