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
2019_register
executive
2019-04-02
article
Nonproprietary Naming of Biological Products: Update; Draft Guidance for Industry; Availability
Notices
D09002ee1bdb7a047
D09002ee1bdb7a0b2
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The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Nonproprietary Naming of Biological Products: Update.'' This draft guidance describes FDA's current thinking on nonproprietary names of biological products licensed under the Public Health Service Act (PHS Act) that do not include an FDA-designated suffix. Specifically, the nonproprietary names of these products need not be revised to accomplish the objectives of the naming convention described in the final guidance for industry, ``Nonproprietary Naming of Biological Products,'' dated January 2017. Similarly, FDA does not intend to apply the naming convention described in the final guidance for industry, ``Nonproprietary Naming of Biological Products,'' to biological products that are the subject of an approved application under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, when such an application is deemed to be a biologics license application (BLA) under the PHS Act (transition biological products). FDA is also reconsidering whether vaccines should be within the scope of the naming convention. In addition, the draft guidance describes FDA's current thinking on the appropriate suffix format for the nonproprietary name of an interchangeable biological product licensed under the PHS Act. Based on the comments received in the docket, we intend to revise the final guidance, ``Nonproprietary Naming of Biological Products,'' dated January 2017 and to amend sections in that document regarding the subjects addressed in this draft guidance.
84 FR 8534
https://www.govinfo.gov/app/details/FR-2019-03-08/2019-04242
2019-04242
fr08mr19-64
4164-01-P
Docket No. FDA-2013-D-1543
https://www.govinfo.gov/app/details/FR-2019-03-08/2019-04242
https://www.govinfo.gov/content/pkg/FR-2019-03-08/html/2019-04242.htm
https://www.govinfo.gov/content/pkg/FR-2019-03-08/pdf/2019-04242.pdf
3 p.
8534
8536
84 FR 8534
Nonproprietary Naming of Biological Products: Update; Draft Guidance for Industry; Availability; Federal Register Vol. 84, Issue
NOTICE
2019-04242
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2019-05-07
Docket No. FDA-2013-D-1543
4164-01-P
2019-04242
Notice of availability.
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Nonproprietary Naming of Biological Products: Update.'' This draft guidance describes FDA's current thinking on nonproprietary names of biological products licensed under the Public Health Service Act (PHS Act) that do not include an FDA-designated suffix. Specifically, the nonproprietary names of these products need not be revised to accomplish the objectives of the naming convention described in the final guidance for industry, ``Nonproprietary Naming of Biological Products,'' dated January 2017. Similarly, FDA does not intend to apply the naming convention described in the final guidance for industry, ``Nonproprietary Naming of Biological Products,'' to biological products that are the subject of an approved application under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, when such an application is deemed to be a biologics license application (BLA) under the PHS Act (transition biological products). FDA is also reconsidering whether vaccines should be within the scope of the naming convention. In addition, the draft guidance describes FDA's current thinking on the appropriate suffix format for the nonproprietary name of an interchangeable biological product licensed under the PHS Act. Based on the comments received in the docket, we intend to revise the final guidance, ``Nonproprietary Naming of Biological Products,'' dated January 2017 and to amend sections in that document regarding the subjects addressed in this draft guidance.
Submit either electronic or written comments on the draft guidance by May 7, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the revisions of the final version of the guidance.
Sandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 6522, Silver Spring, MD 20993-0002, 301- 796-1042; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
Guidance:
Nonproprietary Naming of Biological Products
,
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm
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. 46
Office of the Federal Register, National Archives and Records Administration
2019-03-08
continuing
daily
deposited
born digital
190 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2019-03-08
P0b002ee1a03a9ccc
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr08mr19
https://www.govinfo.gov/app/details/FR-2019-03-08
https://www.govinfo.gov/content/pkg/FR-2019-03-08/pdf/FR-2019-03-08.pdf
https://www.govinfo.gov/content/pkg/FR-2019-03-08/xml/FR-2019-03-08.xml
fdlp
8409
8588
DGPO
2019-04-02
2023-04-28
FR-2019-03-08
machine generated
eng
FR
FR-2019-03-08
84
46