Overview of FDA and Drug Development

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

Volumn , Issue , 2008, Pages 1-32

  Babiarz, Josephine C ^a   Pisano, Douglas J ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

EID: 82755185239     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.3109/9781420073553-4     Document Type: Chapter

References (18)

1. www.fda.gov/oc/FDA’s 2006 Accomplishments/healthcare.html.
2. www.fda.gov/ora/about/enf_story/ch10/FY96toFY06Recalls.pdf.
3. Valentino J. Practical uses for the USP: a legal perspective. In: Strauss’s Federal Drug Laws and Examination Review. 5th ed. Lancaster, PA: Technomic Publishing Co., 1999:38.
4. http://thomas.loc.gov/cgi-bin/bdquery/z?d102:SN02783:@@@D&summ2=m&jTOM:/bss/d102query.html.j
5. www.fda.gov/opacom/laws/dshea.htmo#sec4.
6. www.fda.gov/cder/guidance/3647fnl.pdf.
7. www.fda.gov/cdrh/ode/guidance/1381.html.
8. www.fda.gov/cdrh/mdufma/whitepaper.html
9. Medical Device User Fee and Modernization Act of 2002, Report 107-728 (October 7, 2002), p. 21.
10. www.fda.gov/bbs/transcripts/transcript092707.pdf.
11. Strauss S. Food and Drug Administration: an overview. In: Strauss’s Federal Drug Laws and Examination Review, 5th ed. Lancaster, PA: Technomic Publishing Co., 1999:323.
12. Strauss S. Food and Drug Administration: an overview. In: Strauss’ Federal Drug Laws and Examination Review, 5th ed. Lancaster, PA: Technomic Publishing Co., 1999:176,186.
13. Strauss S. Food and Drug Administration: an overview. Strauss’ Federal Drug Laws and Examination Review. 5th ed. Lancaster, PA: Technomic Publishing Co., 1999:176,186.
14. Pinna K, Pines W. The DRUGS/BIOLOGICS APPROVAL PROCESS. A Practical Guide to Food and Drug Law and Regulation. Washington, DC: FDLI, 1998:98.
15. www.fda.gov/cder/regulatory/applications/nda/htm.
16. www.fda.gov/cder/guidance/index.htm#electronic_submissions.
17. www.fda.gov/ope/pdufa/report2005/PDUFA05perfrpt.pdf.
18. Fundamentals of Regulatory Affairs, Regulatory Affairs Professionals Society, 1999, p. 199.