Marketing New Excipients: Clearing Regulatory Hurdles

Pharmaceutical Technology

Volumn 27, Issue 11, 2003, Pages 102-108

  DeMerlis, Christopher C ^a   Goldring, Jay M ^b  

^a Div of Berwind Pharmaceutical Serv ^*  (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

MARKETING; REGULATORY COMPLIANCE;

EXCIPIENTS;

DRUG PRODUCTS;

EXCIPIENT; NEW DRUG;

CERTIFICATION; DECISION MAKING; DRUG APPROVAL; DRUG FORMULATION; DRUG INFORMATION; DRUG MANUFACTURE; DRUG MARKETING; EVALUATION; FINANCIAL MANAGEMENT; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; LICENSING; REVIEW; SAFETY; TECHNOLOGY; WORKLOAD;

EID: 0242442062     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (6)

1. IPEC-Americas' Web site, http://www.ipecamericas.org (2002).
2. FDA, "Guidance for Industry Drug Product Chemistry, Manufacturing, and Controls Information," http://www.fda.gov/cder/ guidance/1215dft.pdf.
3. FDA, "Guidance for Industry Nonclinical Studies for the Development of Pharmaceutical Excipients," http://www.fda.gov/cber/ gdlns/dvpexcp.pdf.
4. FDA, "Third-Party Review," FDA, Center for Devices and Radiological Health, http:// www.fda.gov/cdrh/thirdparty/.
5. J.E. Foulke, "Cosmetic Ingredients: Understanding the Puffery, " FDA Consumer, 26 (2) (1992).
6. C. DeMerlis, "The IPEC-Americas Excipient Master File Guide," Pharm. Technol. 26 (6) 36-44 (2002).