Works matching DE "BIOLOGICALS -- Law %26 legislation"
Results: 30
WHO guidelines presage US biosimilars legislation?
- Published in:
- Nature Biotechnology, 2009, v. 27, n. 11, p. 963, doi. 10.1038/nbt1109-963a
- By:
- 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:
- 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:
- 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:
- 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:
- Publication type:
- Article
ESSAY: WHEN PATENTS AREN'T ENOUGH: WHY BIOLOGICS NECESSITATE DATA EXCLUSIVITY PROTECTION.
- Published in:
- 2014
- By:
- 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:
- 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:
- 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:
- Publication type:
- Article
Manufacturing Barriers to Biologics Competition and Innovation.
- Published in:
- Iowa Law Review, 2016, v. 101, n. 3, p. 1023
- By:
- Publication type:
- Article
Challenges to Biosimilar Substitution-Reply.
- Published in:
- 2017
- By:
- Publication type:
- Letter
The Pediatric Research Equity Act Moves Into Adolescence.
- Published in:
- 2017
- By:
- Publication type:
- journal article
Improving world health through regulation of biologicals.
- Published in:
- 2006
- Publication type:
- Proceeding
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:
- 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:
- 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:
- 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:
- 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:
- Publication type:
- Article
2009 in reflection.
- Published in:
- 2010
- By:
- 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
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:
- 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:
- 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:
- 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:
- 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:
- 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:
- Publication type:
- Article
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:
- 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
Biosimilars legislation state by state.
- Published in:
- Nature Biotechnology, 2013, v. 31, n. 11, p. 947, doi. 10.1038/nbt1113-947
- Publication type:
- Article