These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
4. PDUFA reauthorization--drug safety's golden moment of opportunity? Hennessy S; Strom BL N Engl J Med; 2007 Apr; 356(17):1703-4. PubMed ID: 17435082 [No Abstract] [Full Text] [Related]
5. Drug safety reform at the FDA--pendulum swing or systematic improvement? McClellan M N Engl J Med; 2007 Apr; 356(17):1700-2. PubMed ID: 17435081 [No Abstract] [Full Text] [Related]
6. Pharmaceuticals and medical devices: FDA oversight. Issue brief. Berry MD Issue Brief Health Policy Track Serv; 2012 Dec; ():1-79. PubMed ID: 23297449 [No Abstract] [Full Text] [Related]
7. Repeal law that puts "FDA on the payroll of the industry," says former NEJM editor. Kmietowicz Z BMJ; 2007 Mar; 334(7591):447. PubMed ID: 17332569 [No Abstract] [Full Text] [Related]
8. User fees to hasten FDA review. Gershon D Nature; 1992 Oct; 359(6396):567. PubMed ID: 1406982 [No Abstract] [Full Text] [Related]
9. Speed, Safety, and Industry Funding - From PDUFA I to PDUFA VI. Darrow JJ; Avorn J; Kesselheim AS N Engl J Med; 2017 Dec; 377(23):2278-2286. PubMed ID: 29211663 [No Abstract] [Full Text] [Related]
10. Playing "kick the FDA"--risk-free to players but hazardous to public health. Wood AJ N Engl J Med; 2008 Apr; 358(17):1774-5. PubMed ID: 18434649 [No Abstract] [Full Text] [Related]
11. Drug safety on trial. Nature; 2005 Mar; 434(7033):545. PubMed ID: 15800579 [No Abstract] [Full Text] [Related]
12. Schering-Plough agrees to pay FDA $500 million and bring factories into compliance. Kuehn BM J Am Vet Med Assoc; 2002 Jul; 221(2):174, 180. PubMed ID: 12118571 [No Abstract] [Full Text] [Related]
13. Pharmaceuticals and medical devices: FDA oversight. ; Berry MD Issue Brief Health Policy Track Serv; 2012 Jan; ():1-86. PubMed ID: 22403845 [No Abstract] [Full Text] [Related]
14. Regulatory watch: impact of PDUFA on regulatory decision-making. Hay M Nat Rev Drug Discov; 2010 Aug; 9(8):585. PubMed ID: 20671755 [No Abstract] [Full Text] [Related]
15. Pharmaceuticals and medical devices: FDA oversight. Berry MD Issue Brief Health Policy Track Serv; 2013 Dec; ():1-123. PubMed ID: 24482893 [No Abstract] [Full Text] [Related]