Regulatory strategy: Preclinical testing of combination products

Medical Device and Diagnostic Industry

Volumn , Issue MAY, 2005, Pages 49-56

  Portnoy, Stuart ^a   Koepke, Steven ^b  

^a PharmaNet Inc   (United States)

^b SRK CONSULTING   (South Africa)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 27844543239     PISSN: 0194844X     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Review

References (8)

1. Aikawa et al. "Lipid Lowering Promotes Accumulation of Mature Smooth Muscle Cells Expressing Smooth Muscle Myosin Heavy Chain Isoforms in Rabbit Atheroma." Circulation Research 83, no. 10 (1998): 1015-1026.
2. Boam, A. "Drug-Eluting Stents: An FDA Case Study." Regulatory Affairs Focus (2003): 18-23.
3. "Definition of Primary Mode of Action of a Combination Product." 21 CFR Part 3; Docket No. 2004N-0194 [on-line]. Federal Register 69, no. 89; available from Internet: www.fda.gov/OHRMS/DOCKETS/98fr/04-10447. pdf.
4. Foy, J. "Common 'Pitfalls' in Drug-Eluting Stent Applications" (paper presented at Cardiovascular Revascularization Therapy Conference) Washington, DC: January 29, 2003.
5. Guidance for Industry: Formal Meetings With Sponsors and Applicants for PDUFA Products [on-line]. Rockville, MD: FDA, CDER and CBER, 2000; available from Internet: www.fda.gov/cder/guidance/2125fnl.pdf.
6. Guidance on IDE Policies and Procedures [on-line]. Rockville, MD: FDA, CDRH, 1998; available from Internet: www.fda.gov/cdrh/ode/idepolcy.html.
7. Guittin, P and Decelle, T. "Future Improvements and Implementation of Animal Care Practices within the Animal Testing Environment" [on-line]. Institute for Laboratory Animal Research Journal Online 43, supplement 2002; available from Internet: http://dels.nas.edu/ilar/jour_online/43_Supp/ v43supGuittin.pdf.
8. Schwartz, Robert S et al. "Drug-Eluting Stents in Preclinical Studies: Recommended Evaluation from a Consensus Group." Circulation 106, no. 14 (2002): 1867-1683.