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Online Results (13)
1.
Biologics and Biosimilars : Background and Key Issues
Author
Johnson, Judith A. (Judith Ann), 1957-
Published
[Washington, D.C.] : Congressional Research Service, 2018-
Online
https://purl.fdlp.gov/GPO/gpo112888
Location
Yale Internet Resource >> None
Format
Online
2.
FDA regulation of follow-on biologics
Author
Johnson, Judith A. (Judith Ann), 1957-
Published
[Washington, D.C.] : Congressional Research Service, 2018-
Online
https://purl.fdlp.gov/GPO/gpo130968
Location
Yale Internet Resource >> None
Format
Online
3.
Biosimilar implementation : a progress report from FDA : hearing before the Subcommittee on Primary Health and Retirement Security of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Fourteenth Congress, first session, on examining biosimilar implementation, focusing on a progress report from FDA, September 17, 2015
Author
United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions. Subcommittee on Primary Health and Retirement Security, author
Published
Washington : U.S. Government Publishing Office, 2017.
Washington, DC : For sale by the Superintendent of Documents, U.S. Government Publishing Office
Location
Library Shelving Facility (LSF) >> Y 4.L 11/4:S.HRG.114-700
Format
Books
4.
Biosimilar implementation : a progress report from FDA : hearing before the Subcommittee on Primary Health and Retirement Security of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Fourteenth Congress, first session ... September 17, 2015
Author
United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions. Subcommittee on Primary Health and Retirement Security, author
Published
Washington : U.S. Government Publishing Office, 2017.
Online
https://purl.fdlp.gov/GPO/gpo86316
Location
Yale Internet Resource >> None
Format
Books / Online
5.
Examining implementation of the Biologics Price Competition and Innovation Act : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Fourteenth Congress, second session, February 4, 2016
Author
United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health, author
Published
Washington : U.S. Government Publishing Office, 2016.
Washington, DC : For sale by the Superintendent of Documents, U.S. Government Publishing Office
Location
Library Shelving Facility (LSF) >> Y 4.C 73/8:114-114
Format
Books
6.
Examining implementation of the Biologics Price Competition and Innovation Act : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Fourteenth Congress, second session, February 4, 2016
Author
United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health, author
Published
Washington : U.S. Government Publishing Office, 2016.
Online
https://purl.fdlp.gov/GPO/gpo76617
Location
Yale Internet Resource >> None
Format
Books / Online
7.
Emerging health care issues : follow-on biologic drug competition : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Eleventh Congress, first session, June 11, 2009
Author
United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Published
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O., 2012.
Online
Online book
Location
HathiTrust Digital Library >> Online Resource
Format
Books / Online
8.
Emerging health care issues follow-on biologic drug competition : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Eleventh Congress, first session, June 11, 2009
Author
United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Published
Washington : U.S. G.P.O., 2012.
Online
http://purl.fdlp.gov/GPO/gpo26033
Location
Yale Internet Resource >> None
Format
Books / Online
9.
Emerging health care issues : follow-on biologic drug competition : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Eleventh Congress, first session, June 11, 2009
Author
United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Published
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O., 2012.
Location
Library Shelving Facility (LSF) >> Y 4.C 73/8:111-46
Format
Books
10.
Biologics and biosimilars : balancing incentives for innovation : hearing before the Subcommittee on Courts and Competition Policy of the Committee on the Judiciary, House of Representatives, One Hundred Eleventh Congress, first session, July 14, 2009
Author
United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts and Competition Policy
Published
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O., 2010.
Location
Library Shelving Facility (LSF) >> Y 4.J 89/1:111-73
Format
Books
11.
Biologics and biosimilars balancing incentives for innovation : hearing before the Subcommittee on Courts and Competition Policy of the Committee on the Judiciary, House of Representatives, One Hundred Eleventh Congress, first session, July 14, 2009
Author
United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts and Competition Policy
Published
Washington : U.S. G.P.O., 2010.
Online
http://purl.access.gpo.gov/GPO/LPS122600
Location
Yale Internet Resource >> None
Format
Books / Online
12.
Biologics and biosimilars : balancing incentives for innovation : hearing before the Subcommittee on Courts and Competition Policy of the Committee on the Judiciary, House of Representatives, One Hundred Eleventh Congress, first session, July 14, 2009
Author
United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts and Competition Policy
Published
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O., 2010.
Online
Online book
Online book
Location
HathiTrust Digital Library >> Online Resource
Format
Books / Online
13.
Follow-on biologics hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Tenth Congress, first session, on examining Food and Drug Administration follow-on biologics, generally referred to as a biotechnology-derived protein drug (or biologic) that is comparable to a novel, previously approved biologic and that is approved with less supporting data than the innovator biologic, March 8, 2007
Author
United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Published
Washington : U.S. G.P.O., 2008.
Online
Text version:
PDF version:
Location
Yale Internet Resource >> None
Format
Books / Online
14.
Follow-on biologics : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Tenth Congress, first session, on examining Food and Drug Administration follow-on biologics, generally referred to as a biotechnology-derived protein drug (or biologic) that is comparable to a novel, previously approved biologic and that is approved with less supporting data than the innovator biologic, March 8, 2007
Author
United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Published
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O., 2008.
Location
Library Shelving Facility (LSF) >> Y 4.L 11/4:S.HRG.110-375
Format
Books
15.
Follow-on biologics hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Tenth Congress, first session, on examining Food and Drug Administration follow-on biologics, generally referred to as a biotechnology-derived protein drug (or biologic) that is comparable to a novel, previously approved biologic and that is approved with less supporting data than the innovator biologic, March 8, 2007
Author
United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Published
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O., 2008.
Online
Online resource
Location
Yale Internet Resource >> None
Format
Books / Online
16.
Follow-on biologics : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Tenth Congress, first session, on examining Food and Drug Administration follow-on biologics, generally referred to as a biotechnology-derived protein drug (or biologic) that is comparable to a novel, previously approved biologic and that is approved with less supporting data than the innovator biologic, March 8, 2007
Author
United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Published
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O., 2008.
Online
4.L 11/4:S.HRG.110-375
Location
HathiTrust Digital Library >> Online Resource
Format
Books / Online
17.
Guidance for industry content and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products
Published
[Rockville, MD] : Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [1995]
Online
http://purl.access.gpo.gov/GPO/LPS118486
Location
Yale Internet Resource >> None
Format
Books / Online
18.
Reinventing regulation of drugs made from biotechnology
Author
Clinton, Bill, 1946-
Published
[Washington, D.C.?] : National Performance Review, [1995]
Location
Library Shelving Facility (LSF) >> PRVP 42.2:D 84/2
Format
Books
19.
Reinventing the regulation of drugs made from biotechnology
Author
Clinton, Bill, 1946-
Published
[Washington, D.C.?] : National Performance Review, [1995]
Online
Online book
Location
HathiTrust Digital Library >> Online Resource
Format
Books / Online