Get 20M+ Full-Text Papers For Less Than $1.50/day. Start a 14-Day Trial for You or Your Team.

Learn More →

Can Expedited FDA Drug Approval Without Expedited Follow-up Be Trusted?

Can Expedited FDA Drug Approval Without Expedited Follow-up Be Trusted? New Drugs Approved by the US FDA in 2008 Original Investigation Research 2. 21 CFR §314.3. Applications for FDA approval to 7. President’s Council of Advisors on Science /GuidanceComplianceRegulatoryInformation market a new drug: definitions. www.gpo.gov/fdsys and Technology. Report to the President on /Guidances/UCM338287.pdf. Accessed April 22, /pkg/CFR-2003-title21-vol5/pdf/CFR-2003-title21 Propelling Innovation in Drug Discovery, 2013. -vol5-sec314-3.pdf. Accessed April 22, 2013. Development and Evaluation. Washington, DC: 12. US Food and Drug Administration. Drug Executive Office of the President of the 3. US Food and Drug Administration. Speeding approvals and databases. www.fda.gov/Drugs United States; September 1, 2012. access to important new therapies—fast track, /InformationOnDrugs/default.htm. Accessed April accelerated approval and priority review. www.fda 8. US Food and Drug Administration. Driving 23, 2013. .gov/forconsumers/byaudience/forpatientadvocates Biomedical Innovation: Initiatives to Improve 13. DailyMed Current Medication Information. US /speedingaccesstoimportantnewtherapies Products for Patients. October 2011. National Library of Medicine website. /ucm128291.htm. Accessed September 20, 2013. www.fda.gov/AboutFDA/ReportsManualsForms http://dailymed.nlm.nih.gov/dailymed/about.cfm. /Reports/ucm274333.htm. Accessed April 22, 2013. 4. International Conference on Harmonization. Accessed April 23, 2013. Guidance for industry: the extent of 9. Creating an alternative approval pathway for 14. 26 USC §45C. Clinical testing expenses for population exposure to assess clinical certain drugs intended to address unmet need. Fed certain drugs for rare http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Internal Medicine American Medical Association

Can Expedited FDA Drug Approval Without Expedited Follow-up Be Trusted?

JAMA Internal Medicine , Volume 174 (1) – Jan 1, 2014

Loading next page...
 
/lp/american-medical-association/can-expedited-fda-drug-approval-without-expedited-follow-up-be-trusted-h5a0Db0RVi
Publisher
American Medical Association
Copyright
Copyright 2014 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
2168-6106
eISSN
2168-6114
DOI
10.1001/jamainternmed.2013.9202
pmid
24165977
Publisher site
See Article on Publisher Site

Abstract

New Drugs Approved by the US FDA in 2008 Original Investigation Research 2. 21 CFR §314.3. Applications for FDA approval to 7. President’s Council of Advisors on Science /GuidanceComplianceRegulatoryInformation market a new drug: definitions. www.gpo.gov/fdsys and Technology. Report to the President on /Guidances/UCM338287.pdf. Accessed April 22, /pkg/CFR-2003-title21-vol5/pdf/CFR-2003-title21 Propelling Innovation in Drug Discovery, 2013. -vol5-sec314-3.pdf. Accessed April 22, 2013. Development and Evaluation. Washington, DC: 12. US Food and Drug Administration. Drug Executive Office of the President of the 3. US Food and Drug Administration. Speeding approvals and databases. www.fda.gov/Drugs United States; September 1, 2012. access to important new therapies—fast track, /InformationOnDrugs/default.htm. Accessed April accelerated approval and priority review. www.fda 8. US Food and Drug Administration. Driving 23, 2013. .gov/forconsumers/byaudience/forpatientadvocates Biomedical Innovation: Initiatives to Improve 13. DailyMed Current Medication Information. US /speedingaccesstoimportantnewtherapies Products for Patients. October 2011. National Library of Medicine website. /ucm128291.htm. Accessed September 20, 2013. www.fda.gov/AboutFDA/ReportsManualsForms http://dailymed.nlm.nih.gov/dailymed/about.cfm. /Reports/ucm274333.htm. Accessed April 22, 2013. 4. International Conference on Harmonization. Accessed April 23, 2013. Guidance for industry: the extent of 9. Creating an alternative approval pathway for 14. 26 USC §45C. Clinical testing expenses for population exposure to assess clinical certain drugs intended to address unmet need. Fed certain drugs for rare

Journal

JAMA Internal MedicineAmerican Medical Association

Published: Jan 1, 2014

References