155 related articles for article (PubMed ID: 22775493)
1. Measuring the patient health, societal and economic benefits of US pediatric therapeutics legislation.
Vernon JA; Shortenhaus SH; Mayer MH; Allen AJ; Golec JH
Paediatr Drugs; 2012 Oct; 14(5):283-94. PubMed ID: 22775493
[TBL] [Abstract][Full Text] [Related]
2. The Best Pharmaceuticals for Children Act of 2002: the rise of the voluntary incentive structure and congressional refusal to require pediatric testing.
Breslow LH
Harvard J Legis; 2003; 40(1):133-93. PubMed ID: 16594116
[TBL] [Abstract][Full Text] [Related]
3. Review of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act: What can the obstetric community learn from the pediatric experience?
Ren Z; Zajicek A
Semin Perinatol; 2015 Nov; 39(7):530-1. PubMed ID: 26455383
[TBL] [Abstract][Full Text] [Related]
4. Pediatric exclusivity: evolving legislation and novel complexities within pediatric therapeutic development.
Rivera DR; Hartzema AG
Ann Pharmacother; 2014 Mar; 48(3):369-79. PubMed ID: 24311725
[TBL] [Abstract][Full Text] [Related]
5. Pediatric research: coming of age in the new millennium.
Milne CP
Am J Ther; 1999 Sep; 6(5):263-82. PubMed ID: 11329108
[TBL] [Abstract][Full Text] [Related]
6. Labeling Changes and Costs for Clinical Trials Performed Under the US Food and Drug Administration Pediatric Exclusivity Extension, 2007 to 2012.
Sinha MS; Najafzadeh M; Rajasingh EK; Love J; Kesselheim AS
JAMA Intern Med; 2018 Nov; 178(11):1458-1466. PubMed ID: 30264138
[TBL] [Abstract][Full Text] [Related]
7. Dermatology Drugs for Children-U.S. Food and Drug Administration Perspective.
Epps RE
Dermatol Clin; 2022 Jul; 40(3):289-296. PubMed ID: 35750412
[TBL] [Abstract][Full Text] [Related]
8. Congress, the FDA, and the fair development of new medications for children.
McKinney RE
Pediatrics; 2003 Sep; 112(3 Pt 1):669-70. PubMed ID: 12949299
[No Abstract] [Full Text] [Related]
9. Safety monitoring of drugs granted exclusivity under the Best Pharmaceuticals for Children Act: what the FDA has learned.
Mathis LL; Iyasu S
Clin Pharmacol Ther; 2007 Aug; 82(2):133-4. PubMed ID: 17632537
[TBL] [Abstract][Full Text] [Related]
10. The Best Pharmaceuticals for Children Act and Pediatric Research Equity Act reach the age of majority-An oncology perspective.
Bernhardt MB; Lindsay H; Allen-Rhoades W; Foster JH
Pediatr Blood Cancer; 2021 Mar; 68(3):e28871. PubMed ID: 33381908
[TBL] [Abstract][Full Text] [Related]
11. Legal and economic perspectives concerning US government investigations of alleged off-label promotion by drug manufacturers.
Kalb PE; Greenberg PE
Pharmacoeconomics; 2009; 27(8):623-5. PubMed ID: 19835018
[No Abstract] [Full Text] [Related]
12. The economics of pediatric formulation development for off-patent drugs.
Milne CP; Bruss JB
Clin Ther; 2008 Nov; 30(11):2133-45. PubMed ID: 19108801
[TBL] [Abstract][Full Text] [Related]
13. Impact of pediatric exclusivity on drug labeling and demonstrations of efficacy.
Wharton GT; Murphy MD; Avant D; Goldsmith JV; Chai G; Rodriguez WJ; Eisenstein EL
Pediatrics; 2014 Aug; 134(2):e512-8. PubMed ID: 25022732
[TBL] [Abstract][Full Text] [Related]
14. Regulatory experts debate FDA's authority.
Young D
Am J Health Syst Pharm; 2007 May; 64(9):910, 912. PubMed ID: 17468140
[No Abstract] [Full Text] [Related]
15. The National Institutes of Health and the Best Pharmaceuticals for Children Act.
Zajicek A
Paediatr Drugs; 2009; 11(1):45-7. PubMed ID: 19127953
[TBL] [Abstract][Full Text] [Related]
16. An Administrative Meter Maid: Using Inter Partes Review and Post-Grant Review to Curb Exclusivity Parking via the "Failure to Market" Provision of the Hatch-Waxman Act.
Apel BT
Mich Law Rev; 2015; 114(1):107-36. PubMed ID: 26394458
[TBL] [Abstract][Full Text] [Related]
17. 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]
18. Economic return of clinical trials performed under the pediatric exclusivity program.
Li JS; Eisenstein EL; Grabowski HG; Reid ED; Mangum B; Schulman KA; Goldsmith JV; Murphy MD; Califf RM; Benjamin DK
JAMA; 2007 Feb; 297(5):480-8. PubMed ID: 17284698
[TBL] [Abstract][Full Text] [Related]
19. Presumption of innocence: FDA's authority to regulate the specifics of prescription drug labeling and the preemption debate.
Dorfman HL; Quinn VM; Brophy EA
Food Drug Law J; 2006; 61(4):585-622. PubMed ID: 17180765
[No Abstract] [Full Text] [Related]
20. The economics of orphan drug policy in the US. Can the legislation be improved?
Peabody JW; Ruby A; Cannon P
Pharmacoeconomics; 1995 Nov; 8(5):374-84. PubMed ID: 10160072
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]