Inadequate Use Of Public Information Leads To Clinical Holds
Inadequate Use Of Public Information Leads To Clinical Holds
1 PagesThe Global 505(b)(2) Experts CamargoPharma.com | 9825 Kenwood Road Cincinnati, OH 45242 USA | (513) 561-3329 Case Study 8 Case Study 8: Inadequate use of public information leads to clinical holds Challenge: A Biotech company had its drug development efforts placed on hold by the FDA by following the advice of a consultant not experienced in the nuances of the 505(b)(2) pathway. Background: The Biotech Com
