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.

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.
Published: (2017)

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.
Published: (2016)

Biologics and Biosimilars : Background and Key Issues /
by: Johnson, Judith A. (Judith Ann), 1957-
Published: (2018)

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: (1995)

FDA regulation of follow-on biologics /
by: Johnson, Judith A. (Judith Ann), 1957-
Published: (2018)

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.
Published: (2012)

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.
Published: (2008)

Reinventing regulation of drugs made from biotechnology.
by: Clinton, Bill, 1946-
Published: (1995)

Follow-on biologics : intellectual property issues /
by: Thomas, John R.
Published: (2018)

Follow-on biologics : the law and intellectual property issues /
by: Thomas, John R., 1967-
Published: (2019)

Biotechnology development and patent law : hearing before the Subcommittee on Intellectual Property and Judicial Administration of the Committee on the Judiciary, House of Representatives, One Hundred Second Congress, first session, November 20, 1991.
Published: (1993)

Biosimilar Implementation : A Progress Report from FDA.
Published: (2015)

Industrial pharmaceutical biotechnology /
by: Klefenz, Heinrich
Published: (2002)

Research and development of vaccines and pharmaceuticals from biotechnology : a guide to effective project management, patenting, and product registration /
by: Gregersen, Jens-Peter
Published: (1994)

Bayh-Dole Act : Selected Issues in Patent Policy and the Commercialization of Technology.
Published: (2008)

Pharmaceutical biotechnology in drug development /
by: Akash, Muhammad Sajid Hamid, et al.
Published: (2023)

Guidance for industry : reports on the status of postmarketing study commitments : implementation of section 130 of the Food and Drug Administration Modernization Act of 1997.
Published: (2006)

Life science inventions : the hurdles of law /
by: Westerlund, Li, 1967-
Published: (2004)

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: (1995)

The challenge of CMC regulatory compliance for biopharmaceuticals and other biologics /
by: Geigert, J. (John), 1948-
Published: (2013)

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.
Published: (2008)

Bioprocessing technology for production of biopharmaceuticals and bioproducts /
Published: (2019)

The race to commercialize biotechnology : molecules, markets, and the state in the United States and Japan /
by: Collins, Steven W. (Steven Wayne), 1960-
Published: (2004)

Biotechnology Patent Protection Act of 1991 : hearing before the Subcommittee on Intellectual Property and Judicial Administration of the Committee on the Judiciary, House of Representatives, One Hundred Second Congress, first session, on H.R. 1417 ... November 21, 1991.
Published: (1993)

Amending Title 35, United States Code, with respect to patents on certain processes : hearing before the Subcommittee on Intellectual Property and Judicial Administration of the Committee on the Judiciary, House of Representatives, One Hundred Third Congress, first session, on H.R. 760 ... June 9, 1993.
Published: (1994)

Nonprescription drugs : considerations regarding a behind-the-counter drug class : report to congressional requesters.
Published: (2009)

Nonprescription drugs : considerations regarding a behind-the-counter drug class : report to congressional requesters.
Published: (2009)

Medical biotechnology : achievements, prospects and perceptions /
by: Sasson, Albert
Published: (2005)

Medical biotechnology : achievements, prospects and perceptions /
by: Sasson, Albert
Published: (2005)

Novel therapeutics from modern biotechnology : from laboratory to human testing /
Published: (1999)

Novel frontiers in the production of compounds for biomedical use /
Published: (2001)

Biosimilars : design and analysis of follow-on biologics /
by: Chow, Shein-Chung, 1955-
Published: (2014)

The challenge of CMC regulatory compliance for biopharmaceuticals /
by: Geigert, J. (John), 1948-
Published: (2004)

Guidance for industry : Q5A viral safety evaluation of biotechnology products derived from cell lines of human or animal origin.
Published: (1998)

Biological security : the risk of dual-use research : hearing before the Committee on Homeland Security and Governmental Affairs, United States Senate, One Hundred Twelfth Congress, second session, April 26, 2012.
Published: (2012)

Biotechnology and biopharmaceuticals : transforming proteins and genes into drugs /
by: Ho, Rodney J. Y.
Published: (2013)