United States Government Publishing Office
publisher
pbl
distributor
dst
United States
National Archives and Records Administration
Office of the Federal Register
author
aut
Government Organization
text
government publication
eng
FR
Regulatory Information
2014_register
executive
2014-10-07
article
Draft Guidance for Industry on Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the Public Health Service Act; Availability
Notices
D09002ee1bdc3e2e8
D09002ee1bdc3e373
United States
Department of Health and Human Services
originator
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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act.'' This draft guidance is intended to assist sponsors developing biological products, sponsors holding biologics license applications (BLAs), and other interested parties in providing information and data that will help the Agency determine the date of first licensure for a reference product under 351(k)(7)(C) of the Public Health Service Act (PHS Act), as added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act amends the PHS Act and other statutes to create an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product.
79 FR 45448
https://www.govinfo.gov/app/details/FR-2014-08-05/2014-18169
2014-18169
fr05au14-66
4164-01-P
Docket No. FDA-2013-D-1165
https://www.govinfo.gov/app/details/FR-2014-08-05/2014-18169
https://www.govinfo.gov/content/pkg/FR-2014-08-05/html/2014-18169.htm
https://www.govinfo.gov/content/pkg/FR-2014-08-05/pdf/2014-18169.pdf
3 p.
45448
45450
79 FR 45448
Draft Guidance for Industry on Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the Public Health Service Act; Availability; Federal Register Vol. 79, Issue
NOTICE
2014-18169
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2013-D-1165
4164-01-P
2014-18169
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act.'' This draft guidance is intended to assist sponsors developing biological products, sponsors holding biologics license applications (BLAs), and other interested parties in providing information and data that will help the Agency determine the date of first licensure for a reference product under 351(k)(7)(C) of the Public Health Service Act (PHS Act), as added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act amends the PHS Act and other statutes to create an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product.
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 October 6, 2014. Submit either electronic or written comments concerning the proposed collection of information by October 6, 2014.
Sandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301- 796-1042; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
Guidance:
Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the Public Health Service Act; Availability
,
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.regulations.gov
Federal Register
Vol. 79, no. 150
Office of the Federal Register, National Archives and Records Administration
2014-08-05
continuing
daily
deposited
born digital
368 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2014-08-05
P0b002ee189da16c3
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr05au14
https://www.govinfo.gov/app/details/FR-2014-08-05
https://www.govinfo.gov/content/pkg/FR-2014-08-05/pdf/FR-2014-08-05.pdf
https://www.govinfo.gov/content/pkg/FR-2014-08-05/xml/FR-2014-08-05.xml
fdlp
45309
45669
DGPO
2014-10-07
2023-04-29
FR-2014-08-05
machine generated
eng
FR
FR-2014-08-05
79
150