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John M. ("Jack") Davitt, MS

John M. ("Jack") Davitt, MS is a former CDER Supervisory Pharmacologist with 27 years experience at FDA, involved primarily in the review and evaluation of nonclinical pharmacology and toxicology data submitted in support of new drug applications (INDs, NDAs). He has been a regulatory toxicology consultant to the pharmaceutical industry for 17 years. Mr. Davitt holds a MS in pharmacology from the University of Michigan. He is a registered pharmacist.

Among the services I can provide are:

Advising on strategy for toxicological assessment of drug products intended for human use. Placing and monitoring nonclinical studies, as needed.
Review of existing pertinent toxicological information, including scientific literature search.
Due diligence assessment.
Preparation of nonclinical toxicology summaries for regulatory submissions to FDA:

Investigational New Drug Applications (INDs)

- initial and subsequent submissions - toxicology summaries and IBs

- including Pre-IND, Annual Report and End-of-Phase II submissions

New Drug Applications (NDAs)

- CTD format