The FDA safety and innovation act

JAMA

Volumn 308, Issue 14, 2012, Pages 1437-1438

  Steinbrook, Robert ^a   Sharfstein, Joshua M ^b  

^a YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b MARYLAND DEPARTMENT OF HEALTH AND MENTAL HYGIENE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; GENERIC DRUG;

DRUG APPROVAL; DRUG COST; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG QUALITY; DRUG USE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE COST; HUMAN; INFECTION; LAW; MEDICAL DEVICE; OUTPATIENT CARE; PRESCRIPTION; PRIORITY JOURNAL; PUBLIC HEALTH; SAFETY; SHORT SURVEY; UNITED STATES;

EID: 84867150177     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2012.12829     Document Type: Short Survey

References (7)

1. Food and Drug Administration Safety and Innovation Act, S 3187, 112th Cong, Pub L No. 122-144 (2012). http://www.gpo.gov/fdsys/pkg/PLAW-112publ144/ html/PLAW-112publ144.htm. Accessed September 11, 2012.
2. Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill, 2013, S 112-163, 112th Cong, 2nd Sess (2012). http://www.gpo.gov/fdsys/pkg/CRPT-112srpt163/pdf/CRPT-112srpt163.pdf. Accessed September 11, 2012.
3. Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill, 2013, HR 112-542, 112th Cong, 2nd Sess (2012). http://www.gpo.gov/fdsys/pkg/CRPT-112hrpt542/pdf/CRPT-112hrpt542.pdf. Accessed September 11, 2012.
4. Institute of Medicine. Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years.Washington, DC: National Academies Press; 2011. http://www.iom.edu/Reports/2011/Medical-Devices-and-the-Publics-Health- The-FDA-510k-Clearance-Process-at-35-Years.aspx. Accessed September 11, 2012.
5. Institute of Medicine. Ethical and Scientific Issues in Studying the Safety of Approved Drugs. Washington, DC: National Academies Press; 2012. http://www.iom.edu/Reports/2012/Ethical-and-Scientific-Issues-in-Studying-the- Safety-of-Approved-Drugs.aspx. Accessed September 11, 2012.
6. Trial and Experimental Studies Transparency Act of 2012, HR 6272, 112th Cong, 2nd Sess (2012). http://thomas.loc.gov/cgi-bin/query/z?c112:H.R.6272. Accessed September 11, 2012.
7. California Senate Bill No. 1307, Pharmacy: Pedigree. http://leginfo. legislature.ca.gov/faces/billNavClient.xhtml?bill-id=200720080SB1307&search -keywords=. Accessed September 11, 2012.