Falls Church, VA (PRWEB) December 17, 2013
FDA Complete Response Letter Analysis:
How 51 Companies Turned Failure to Success
**FDAnews Management Report **
A complete response letter (CRL) from the FDA delays a product’s entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them.
Imagine how much a company could save if it could anticipate the FDA’s concerns and address them before the agency issues the complete response letter?
Researcher Theresa Allio, Ph.D., analyzed CRLs issued for 51 products approved by the FDA since 2009 and discovered striking underlying patterns:
Reading FDA Complete Response Letter Analysis can be an eye-opening experience. Discover the:
ABOUT THE AUTHOR
Theresa Allio Ph.D. has 10 years’ experience in drug development, including service in academia, industry and the FDA. She started her career at Vertex Pharmaceuticals, serving a key regulatory role on the Incivek and Kalydeco development teams. While at the FDA, she served as a nonclinical reviewer and as support staff for the Pediatric Advisory Committee.
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