343 related articles for article (PubMed ID: 25291306)
1. A cheat sheet to navigate the complex maze of exclusivities in the United States.
Peng B; Tomas MC
Pharm Pat Anal; 2014 Jul; 3(4):339-43. PubMed ID: 25291306
[No Abstract] [Full Text] [Related]
2. Balancing US patent and FDA approval processes: strategically optimizing market exclusivity.
Fernandez DS; Huie JT
Drug Discov Today; 2004 Jun; 9(12):509-12. PubMed ID: 15183155
[No Abstract] [Full Text] [Related]
3. A precarious balancing act--the role of the FDA as protector of public health and industry wealth.
McCabe AR
Suffolk Univ Law Rev; 2003; 36(3):787-819. PubMed ID: 16493844
[No Abstract] [Full Text] [Related]
4. Pediatric Exclusivity and Regulatory Authority: Implications of Amgen v HHS.
Kim J; Ross JS; Kapczynski A
JAMA; 2018 Jan; 319(1):21-22. PubMed ID: 29117365
[No Abstract] [Full Text] [Related]
5. Drug discovery market exclusivity after KSR: the challenge to pharmaceutical scientists and the US congress.
Wolff ME
J Pharm Sci; 2011 Aug; 100(8):3044-3054. PubMed ID: 21472728
[TBL] [Abstract][Full Text] [Related]
6. Biosimilars in the United States: Emerging Issues in Litigation.
Wong AY; Rumore MM; Chan AW
BioDrugs; 2017 Jun; 31(3):189-205. PubMed ID: 28424972
[TBL] [Abstract][Full Text] [Related]
7. Understanding the Rewards of Successful Drug Development - Thinking Inside the Box.
Khullar D; Ohn JA; Trusheim M; Bach PB
N Engl J Med; 2020 Jan; 382(5):473-480. PubMed ID: 31995697
[No Abstract] [Full Text] [Related]
8. The application of the patent laws to the drug approval process.
Coggio BD; Cerrito FD
Food Drug Law J; 1997; 52(4):345-55. PubMed ID: 10346669
[No Abstract] [Full Text] [Related]
9. Old drugs, new uses: solving a Hatch-Waxman patent predicament.
McPhie DC
Food Drug Law J; 2004; 59(1):155-68. PubMed ID: 15190929
[No Abstract] [Full Text] [Related]
10. The End of "Patent Medicines"? Thoughts on the Rise of Regulatory Exclusivities.
Thomas JR
Food Drug Law J; 2015; 70(1):39-53. PubMed ID: 26292471
[No Abstract] [Full Text] [Related]
11. The Drug Price Competition and Patent Term Restoration Act of 1984: fine-tuning the balance between the interests of pioneer and generic drug manufacturers.
Soehnge H
Food Drug Law J; 2003; 58(1):51-80. PubMed ID: 12739584
[No Abstract] [Full Text] [Related]
12. Informed by the European Union experience: what the United States can anticipate and learn from the European Union's regulatory approach to biosimilars.
Gitter DM
Seton Hall Law Rev; 2011; 41(2):559-92. PubMed ID: 21739759
[No Abstract] [Full Text] [Related]
13. A cheat sheet to navigate the complex maze of pharmaceutical exclusivities in Europe.
Tomas MC; Peng B
Pharm Pat Anal; 2017 Jul; 6(4):161-170. PubMed ID: 28696178
[TBL] [Abstract][Full Text] [Related]
14. Pharmaceuticals and medical devices: business practices. Issue brief.
Steiner DJ
Issue Brief Health Policy Track Serv; 2012 Dec; ():1-36. PubMed ID: 23297448
[No Abstract] [Full Text] [Related]
15. Market exclusivity for biologics.
Wheadon DE
N Engl J Med; 2010 Feb; 362(7):661; author reply 661-2. PubMed ID: 20164494
[No Abstract] [Full Text] [Related]
16. Realizing two-tiered innovation policy through drug regulation.
Ridgway WE
Stanford Law Rev; 2006 Feb; 58(4):1221-50. PubMed ID: 16685807
[No Abstract] [Full Text] [Related]
17. Bracing for the biosimilar wave.
Mullard A
Nat Rev Drug Discov; 2017 Mar; 16(3):152-154. PubMed ID: 28248938
[No Abstract] [Full Text] [Related]
18. The ongoing regulation of generic drugs.
Frank RG
N Engl J Med; 2007 Nov; 357(20):1993-6. PubMed ID: 18003956
[No Abstract] [Full Text] [Related]
19. On access and accountability--two Supreme Court rulings on generic drugs.
Boumil MM; Curfman GD
N Engl J Med; 2013 Aug; 369(8):696-7. PubMed ID: 23923990
[No Abstract] [Full Text] [Related]
20. The problem of new uses.
Eisenberg RS
Yale J Health Policy Law Ethics; 2005; 5(2):717-39. PubMed ID: 16052897
[No Abstract] [Full Text] [Related]
[Next] [New Search]