Drug Information Association, Online
May 9 2007
Unique Opportunity to Have Key FDA Representatives Answer All Your Questions About the Draft Guidance for Target Product Profiles: Strategic Development Process Tools
An efficient dialogue between a sponsor and the FDA during the drug development process can minimize the risk of late-stage drug development failures, increase the probability that optimal safety and efficacy data are available in a timely manner, improve labeling content, and decrease the time involved with drug development.
In March 2007, FDA published the Draft Guidance for Industry and Review Staff: Target Product Profile – A Strategic Development Process Tool. This Guidance will provide sponsors and the review staff in the Center for Drug Evaluation and Research at the FDA with information regarding target product profiles (TPPs). A TPP is a format for a summary of a drug development program (both human drugs and therapeutic biological products) described in terms of labeling concepts.
||1)CHERYL BEAL ANDERSON,, PharrmD,,
Director, US Regulatory Affairs
Eli Lilly and Company
2)INGRID BRYZINSKI,, MS,, RPh
Director, Strategic Global Labeling
3)LAURIE B. BURKE, RPh, MPH,
Director, Study Endpoints and Label
Development Team, Office of New Drugs,
4)JEANNE M. DELASKO, RN, MS
Label Initiatives Specialist, Study Endpoints
and Label Development, Office of New Drugs,