The New Drug Application

Fda Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition

Volumn , Issue , 2008, Pages 69-108

  Monahan, Charles ^a   Babiarz, Josephine C ^b  

^a Clinical Research   (United States)

^b MASSACHUSETTS COLLEGE OF PHARMACY AND HEALTH SCIENCES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84976425907     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.3109/9781420073553-6     Document Type: Chapter

References (15)

1. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=7c6ebbb3acf53d253acbcf58ee31d425&rgn=div8&view=text&node=21:5.0.1.1.4.1.1.2&idno=21.
2. www.fda.gov/fdac/special/testtubetopatient/drugreview.html.
3. www.fda.gov/cder/pdufa/2008_rates.htm www.fda.gov/cber/inside/fastrk.htm.
4. www.fda.gov/cder/handbook/develop.htm.
5. http://www.fda.gov/cder/guidance/5645fnl.htm#_Toc77574464. 16 Available at: http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=7c6ebbb3acf53d253acbcf58ee31d425&rgn=div8&view=text&node=21:5.0.1.1.4.2.1.1&idno=21.
6. Form 356h is available at: www.fda.gov/opacom/morechoices/fdaforms/356Hes.pdf.
7. The form can be found at http://www.fda.gov/opacom/morechoices/fdaforms/FDA-3542a.pdf.
8. http://www.fda.gov/cber/gdlns/debar.pdf.
9. www.fda.gov/cder/guidance/7621dft.pdf [dated 07-2-2007].
10. http://www.ich.org/cache/compo/276-254-1.html.
11. www.fda.gov/cder/guidance/6673fnl.htm; December 2004, Rev. 3.
12. www.fda.gov/cder/guidance/4539E.htm.
13. www.fda.gov/cder/guidance/4539Q.htm.
14. www.fda.gov/cder/guidance/4539S.htm.
15. www.fda.gov/cder/present/DIA62002/molzon/sld006.htm.