Presents CDER Review Division a Discipline review processes at a relatively high level since the conceptual, application, a legal dimensions of electronic submissions remain developmental. Provides a solid framework for constructing CANDA submissions a a perspective for the future growth of electronic submissions.Documents Package Insert CRFs ~ Drug Response % Adverse Drug aFDA sponsor ~aaSpot Audit Analyses Event ... Claim ~ai Data Study ~Vital Signs Review at Summarize All Monitoring aWith New Criteria Agreements Conunitteeanbsp;...
|Title||:||Computer Assisted New Drug Application (CANDA) Guidance Manual (1994)|
|Author||:||DIANE Publishing Company|
|Publisher||:||DIANE Publishing - 1995-08|