User fees and beyond - The FDA safety and innovation act of 2012

New England Journal of Medicine

Volumn 367, Issue 14, 2012, Pages 1277-1279

  Kramer, Daniel B ^a,b   Kesselheim, Aaron S ^a,c  

^a HARVARD MEDICAL SCHOOL   (United States)

^b BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^c BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; GENERIC DRUG; NEW DRUG;

ACT; DEVICE APPROVAL; DEVICE RECALL; DEVICE SAFETY; DRUG APPROVAL; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FEE; FOOD AND DRUG ADMINISTRATION; INFORMATION TECHNOLOGY; PATIENT SAFETY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PROGRAM DEVELOPMENT; SAFETY AND INNOVATION ACT; SHORT SURVEY; STANDARD; UNITED STATES;

EID: 84867177653     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1207800     Document Type: Article

References (4)

1. Food and Drug Administration Safety and Innovation Act (http://www.gpo.gov/fdsys/pkg/BILLS-112s3187enr/pdf/BILLS-112s3187enr.pdf).
2. Downing NS, Aminawung JA, Shah ND, Braunstein JB, Krumholz HM, Ross JS. Regulatory review of novel therapeutics - comparison of three regulatory agencies. N Engl J Med 2012;366:2284-93.
3. Roberts SA, Allen JD, Sigal EV. Despite criticism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe. Health Aff (Millwood) 2011;30:1375-81.
4. Alpert B. Vitter amendment to speed generic drugs to market fails. New Orleans Times-Picayune. May 24, 2012 (http://www.nola.com/politics/index.ssf/ 2012/05/vitter-amendment-to-speed-gene.html).