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1.
Follow-on biologics : the law and intellectual property issues
Author
Thomas, John R., 1967-
Published
[Washington, D.C.] : Congressional Research Service, 2019-
Online
https://purl.fdlp.gov/GPO/gpo124119
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.
Follow-on biologics : intellectual property issues
Author
Thomas, John R.
Published
[Washington, D.C.] : Congressional Research Service, [2018?]-
Online
https://purl.fdlp.gov/GPO/gpo126257
Location
Yale Internet Resource >> None
Format
Online
4.
Reforming biopharmaceutical pricing at home and abroad
Published
[Washington, D.C.] : Executive Office of the President of the United States, Council of Economic Advisers, 2018.
Online
https://purl.fdlp.gov/GPO/gpo90462
Location
Yale Internet Resource >> None
Format
Books / Online
5.
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
6.
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
7.
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
8.
Detailed Outline of the Promoting Innovations and Access to Life-Saving Medicine Act
Author
United States. Congress. House. Committee on Energy and Commerce
Published
[Washington : U.S. G.P.O.], 2009.
Online
Online resource
Location
Yale Internet Resource >> None
Format
Books / Online
9.
Principal Differences Between the "Promoting Innovation and Access to Life-Saving Medicine Act" and the "Access to Life-Saving Medicine Act" Introduced in the 110th Congress
Author
United States. Congress. House. Committee on Energy and Commerce
Published
[Washington : U.S. G.P.O.], 2009.
Online
Online resource
Location
Yale Internet Resource >> None
Format
Books / Online
10.
Promoting Innovation and Access to Life-Saving Medicine Act
Author
United States. Congress. House. Committee on Energy and Commerce
Published
[Washington : U.S. G.P.O.], 2009.
Online
Online resource
Location
Yale Internet Resource >> None
Format
Books / Online
11.
Q's and A's on the "Promoting Innovation and Access to Life-Saving Medicine Act"
Author
United States. Congress. House. Committee on Energy and Commerce
Published
[Washington : U.S. G.P.O.], 2009.
Online
Online resource
Location
Yale Internet Resource >> None
Format
Books / Online
12.
Assessing the impact of a safe and equitable biosimilar policy in the United States hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, May 2, 2007
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., 2008.
Online
Online resource
Location
Yale Internet Resource >> None
Format
Books / Online
13.
Assessing the impact of a safe and equitable biosimilar policy in the United States : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, first session, May 2, 2007
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., 2008.
Online
4.C 73/8:110-40
Location
HathiTrust Digital Library >> Online Resource
Format
Books / Online
14.
Emerging safety science workshop summary
Published
Washington, D.C. : National Academies Press, c2008.
Online
Online book
Location
Yale Internet Resource >> None
Format
Books / Online
15.
Emerging safety science workshop summary
Published
Washington, DC : National Academies Press, c2008.
Online
Online book
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., 2008.
Online
Text version:
PDF version:
Location
Yale Internet Resource >> None
Format
Books / Online
17.
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
18.
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
19.
Safe and affordable biotech drugs : the need for a generic pathway : hearing before the Committee on Oversight and Government Reform, House of Representatives, One Hundred Tenth Congress, first session, March 26, 2007
Author
United States. Congress. House. Committee on Oversight and Government Reform
Published
Washington : U.S. G.P.O. : For sale by the Supt. of Docs., U.S. G.P.O., 2008.
Online
4.G 74/7:110-43
Location
HathiTrust Digital Library >> Online Resource
Format
Books / Online
20.
Safe and affordable biotech drugs the need for a generic pathway : hearing before the Committee on Oversight and Government Reform, House of Representatives, One Hundred Tenth Congress, first session, March 26, 2007
Author
United States. Congress. House. Committee on Oversight and Government Reform
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
21.
Guidance for industry manufacturing biological intermediates and biological drug substances using spore-forming microorganisms
Published
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2007]
Online
http://purl.access.gpo.gov/GPO/LPS112355
Location
Yale Internet Resource >> None
Format
Books / Online
22.
Guidance for industry drugs, biologics and medical devices derived from bioengineered plants for use in humans and animals
Published
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2002]
Online
http://purl.access.gpo.gov/GPO/LPS120756
Location
Yale Internet Resource >> None
Format
Books / Online
23.
Guidance for industry Q5A viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
Published
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [1998]
Online
http://purl.access.gpo.gov/GPO/LPS117637
Location
Yale Internet Resource >> None
Format
Books / Online
24.
Biotechnology in a global economy hearing before the Subcommittee on Environment of the Committee on Science, Space, and Technology, U.S. House of Representatives, One Hundred Second Congress, first session, December 16, 1991
Author
United States. Congress. House. Committee on Science, Space, and Technology. Subcommittee on Environment
Published
Washington : U.S. G.P.O., 1992.
Online
Online resource
Location
Yale Internet Resource >> None
Format
Books / Online