Works matching DE "BIOLOGICALS -- Law %26 legislation"

Results: 30

Safety-Related Regulatory Actions for Biologicals Approved in the United States and the European Union.

Published in:

JAMA: Journal of the American Medical Association, 2008, v. 300, n. 16, p. 1887, doi. 10.1001/jama.300.16.1887

By:

Giezen, Thijs J.;
Mantel-Teeuwisse, Aukje K.;
Straus, Sabine M. J. M.;
Schellekens, Huub;
Leufkens, Hubert G. M.;
Egberts, Antoine C. G.

Publication type:

Article

"SHALL" WE DANCE? INTERPRETING THE BPCIA'S PATENT PROVISIONS.

Published in:

Berkeley Technology Law Journal, 2016, v. 31, p. 659, doi. 10.15779/Z383S0S

By:

Tanaka, Jon

Publication type:

Article

US health bill promises changes for biomedical researchers.

Published in:

Nature, 2010, v. 464, n. 7288, p. 479, doi. 10.1038/464479a

By:

Wadman, Meredith

Publication type:

Article

Analysis of the BPCIA, the Pre-Approval Patent Resolution Process, Regulatory Exclusivity Periods, and Complementary Rules Affecting Patent Terms.

Published in:

BioProcessing Journal, 2012, v. 11, n. 1, p. 11

By:

Luckow, Verne A.

Publication type:

Article

Improving world health through regulation of biologicals.

Published in:: 2006
Publication type:: Proceeding

ESSAY: WHEN PATENTS AREN'T ENOUGH: WHY BIOLOGICS NECESSITATE DATA EXCLUSIVITY PROTECTION.

Published in:

2014

By:

Lybecker, Kristina M.

Publication type:

Essay

THE HATCH-WAXMAN ACT: A PATH FORWARD FOR MAKING IT MORE MODERN.

Published in:

William Mitchell Law Review, 2014, v. 40, n. 4, p. 1200

By:

Armitage, Robert A.

Publication type:

Article

Decisions hint that not all biologics are created with equal ease.

Published in:

Nature Medicine, 2010, v. 16, n. 11, p. 1171, doi. 10.1038/nm1110-1171

By:

Hutson, Stu

Publication type:

Article

Industry's influence in biologics legislation examined.

Published in:

Nature Medicine, 2010, v. 16, n. 3, p. 245, doi. 10.1038/nm0310-245b

By:

Dolgin, Elie

Publication type:

Article

Biosimilars legislation awakens data exclusivity debate.

Published in:

Nature Medicine, 2009, v. 15, n. 11, p. 1242, doi. 10.1038/nm1109-1242a

By:

Hutson, Stu

Publication type:

Article

The Role of Physiologically Based Pharmacokinetic Modeling in Regulatory Review.

Published in:

Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 542, doi. 10.1038/clpt.2011.320

By:

Huang, S-M;
Rowland, M

Publication type:

Article

Seeking clarity regarding The BPCIA.

Published in:

Journal of Generic Medicines, 2015, v. 12, n. 2, p. 74, doi. 10.1177/1741134315618536

By:

Browning, Jill M.;
Vorozhbit, Svetlana

Publication type:

Article

Patent watch: Have the biosimilar floodgates been opened in the United States?

Published in:

Nature Reviews Drug Discovery, 2015, v. 14, n. 5, p. 303, doi. 10.1038/nrd4622

By:

Brinckerhoff, Courtenay C.;
Schorr, Kristel

Publication type:

Article

2009 in reflection.

Published in:

2010

By:

Hughes, Bethan

Publication type:

journal article

Risks, returns and reassurance.

Published in:: Nature Reviews Drug Discovery, 2008, v. 7, n. 7, p. 545, doi. 10.1038/nrd2631
Publication type:: Article

The New Era of Biologic Regulation and Patenting Under the America Invents Act.

Published in:

Marquette Intellectual Property Law Review, 2014, v. 18, n. 1, p. 107

By:

RUCKER, DAVID I.

Publication type:

Article

THE HATCH-WAXMAN ACT'S SIDE EFFECTS: PRECAUTIONS FOR BIOSIMILARS.

Published in:

Loyola of Los Angeles Law Review, 2014, v. 47, n. 4, p. 917

By:

Laakmann, Anna B.

Publication type:

Article

General.

Published in:: WHO Technical Report Series, 2011, n. 964, p. 3
Publication type:: Article

Introduction.

Published in:: WHO Technical Report Series, 2011, n. 964, p. 1
Publication type:: Article

Biopharmaceuticals Under the Patient Protection and Affordable Care Act: Determining the Appropriate Market and Data Exclusivity Periods.

Published in:

Texas Intellectual Property Law Journal, 2013, v. 21, n. 2, p. 213

By:

Gitter, Donna M.

Publication type:

Article

Biosimilars legislation state by state.

Published in:: Nature Biotechnology, 2013, v. 31, n. 11, p. 947, doi. 10.1038/nbt1113-947
Publication type:: Article

State-level legislation on follow-on biologic substitution.

Published in:

Journal of Law & the Biosciences, 2014, v. 1, n. 2, p. 190, doi. 10.1093/jlb/lsu005

By:

Benedict, Adriana Lee

Publication type:

Article

Implementation of the Biosimilar Pathway: Economic and Policy Issues.

Published in:

Seton Hall Law Review, 2011, v. 41, n. 2, p. 511

By:

Grabowski, Heniy;
Long, Genia;
Mortimer, Richard

Publication type:

Article

Challenges to Biosimilar Substitution-Reply.

Published in:

2017

By:

Hakim, Aaron;
Ross, Joseph S.

Publication type:

Letter

The Pediatric Research Equity Act Moves Into Adolescence.

Published in:

2017

By:

Bourgeois, Florence T.;
Hwang, Thomas J.

Publication type:

journal article

WHO guidelines presage US biosimilars legislation?

Published in:

Nature Biotechnology, 2009, v. 27, n. 11, p. 963, doi. 10.1038/nbt1109-963a

By:

Hodgson, John

Publication type:

Article

Enforcing pharmaceutical and biotech patent rights in China.

Published in:

Nature Biotechnology, 2008, v. 26, n. 11, p. 1235, doi. 10.1038/nbt1108-1235

By:

Zhang, Y Philip;
Deng, Michelle M

Publication type:

Article

Western biotechs ponder follow-on possibilities.

Published in:

Nature Biotechnology, 2008, v. 26, n. 9, p. 962, doi. 10.1038/nbt0908-962

By:

Waltz, Emily

Publication type:

Article

Manufacturing Barriers to Biologics Competition and Innovation.

Published in:

Iowa Law Review, 2016, v. 101, n. 3, p. 1023

By:

Price II, W. Nicholson;
Rai, Arti K.

Publication type:

Article

USING DATA EXCLUSIVITY GRANTS TO INCENTIVIZE CUMULATIVE INNOVATION OF BIOLOGICS’ MANUFACTURING PROCESSES.

Published in:

American University Law Review, 2017, v. 66, n. 3, p. 911

By:

LEVI, ERIC LAWRENCE

Publication type:

Article