This Interactive Qualifying Project (IQP) sets forth guidelines and offers advice as to how companies can increase the success rates for the approval of their products during clinical trials with the aim of attaining and maintaining Food and Drug Administration (FDA) approval. FDA actions against non-conforming products and corporation were studied. Advice concerning validation considerations throughout the entire approval process and beyond was addressed with special attention to current Good Manufacturing Practices and software/control system validation. The societal and economic impacts of the entire regulatory affair were examined centering upon pharmaceuticals, including Zomax, EPO, Triazure, Vasotec, Serc and Pulmozyme, including the integratory effects of improved approval success rates.

• This report represents the work of one or more WPI undergraduate students submitted to the faculty as evidence of completion of a degree requirement. WPI routinely publishes these reports on its website without editorial or peer review.

Creator

• Pazzano, David

Subject

• Well-Being
• Industry
• Health
• Security

Publisher

• Worcester Polytechnic Institute

Identifier

• 99E008I

Keyword

• Organizational effectiveness

Advisor

• Adams, David S.

Year

• 1999

Sponsor

• VTS, Inc

Date created

• 1999-01-01

Location

• Worcester

Resource type

• Interactive Qualifying Project

Rights statement

• In Copyright