Flexibility and innovation in the FDA’s novel regulatory approval strategies for hematologic drugs-Reference-Cited by-同舟云学术

Flexibility and innovation in the FDA’s novel regulatory approval strategies for hematologic drugs

Published:2017-09-14 Issue:11 Volume:130 Page:1285-1289
ISSN:0006-4971
Container-title:Blood
language:en
Short-container-title:

Author:

Farrell Ann T.¹,Goldberg Kirsten B.¹^ORCID,Pazdur Richard¹²^ORCID

Affiliation:

1. Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, and

2. Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD

Publisher

American Society of Hematology

Subject

Cell Biology,Hematology,Immunology,Biochemistry

Link

http://ashpublications.org/blood/article-pdf/130/11/1285/1402216/blood742726.pdf

Reference21 articles.

1. Code of Federal Regulations §21-314. Applications for FDA approval to market a new drug. https://www.ecfr.gov/cgi-bin/text-idx?SID=010a94318c67beab1667440e18632a2f&mc=true&tpl=/ecfrbrowse/Title21/21cfr314_main_02.tpl. Accessed 4 April 2017.

2. Code of Federal Regulations §21-601. Licensing. https://www.ecfr.gov/cgi-bin/text-idx?SID=51c955e0ef369e2db2f0c3745a065028&mc=true&tpl=/ecfrbrowse/Title21/21cfr601_main_02.tpl. Accessed 4 April 2017.

3. US Food and Drug Administration. Guidance for industry: expedited programs for serious conditions–drugs and biologics (May 2014). http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf. Accessed 4 April 2017.

4. U.S. Food and Drug Administration. CDER breakthrough therapy designation approvals as of Dec. 31, 2016. https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/NDAandBLAApprovalReports/UCM481542.pdf. Accessed 4 April 2017.

5. Code of Federal Regulations §21-314.500. Scope. https://www.ecfr.gov/cgi-bin/text-idx?SID=7bf54b0bb4290e41dc98c39e6ec242fe&mc=true&node=se21.5.314_1500&rgn=div8. Accessed 4 April 2017.

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