State of the union: Drug-device combinations

Medical Device and Diagnostic Industry

Volumn 28, Issue 11, 2006, Pages 48-55

  Gibbs, Jeffrey ^a  

^a Hyman Phelps and McNamara P C ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG COMPANY; DRUG DELIVERY SYSTEMS; DRUG ELUTING STENTS; ORTHOPEDIC IMPLANTS;

BIOMEDICAL EQUIPMENT; CONTROLLED DRUG DELIVERY; DRUG PRODUCTS; IMPLANTS (SURGICAL); REGULATORY COMPLIANCE;

SOCIETIES AND INSTITUTIONS;

EID: 33751086490     PISSN: 0194844X     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Conference Paper

References (11)

1. Mark D Kramer, "Combination Products: Challenges and Progress," Regulatory Affairs Focus (August 2005): 33.
2. Federal Register, 71 FR:E6-01918, February 13, 2006.
3. Medical Device Innovation Initiative, (Rockville, MD: FDA, CDRH, May 2006).
4. Critical Path Opportunities Report (Rockville, MD: FDA, 2006).
5. Federal Register, 71 FR:06-354, January 17, 2006.
6. Joseph DiMasi et al., "The Price of Innovation: New Estimates of Drug Development Costs," Journal of Health, Economics 22 (2003): 151-185.
7. United States v. Gugnani, 1768 F.:supp. 2d 538 (D.Md.), Trial Testimony of Robert Sheridan (August 21, 2000).
8. David M Fox and Jeffrey K Shapiro, "Combination Products: How to Develop the Optimal Strategic Path for Approval" (FDA News 2005).
9. Federal Register, 70 FR:05-16527, August 25, 2005.
10. Orphan Drug Act, 21 U.S.C. sect. 360 (aa)-360(ee).
11. Drug Price Competition and Patent Term Restoration Act of 1984, 21 U.S.C. sect. 355.