APPLICATION INTEGRITY POLICY Contact List

 List of Application Integrity Policy (AIP) Committee Members and AIP Contact Persons
(Updated May 22, 2008)

[FDA removed the AIP procedures and the following contact list from the internet version of Regulatory Procedures Manual (RPM), Chapter 10, when the agency updated the RPM in 2004.]

Center for Biologics Evaluation and Research:

Diane Alexander, HFM-610, Ph 301-827-6201, FAX 301-594-0940
Patricia Holobaugh, HFM-664, Ph 301-827-6347, FAX 301-827-6748

Center for Devices and Radiological Health:

Carl T. DeMarco, R.Ph., J.D., HFZ-400, Ph 240-276-3993, FAX 240-276-3977
Sonali P. Gunawardhana, J.D., HFZ-310, Ph 240-276-0246, FAX 240-276-0128
Michael Marcarelli, PharmD., HFZ-310, Ph 240-276-0244, FAX 240-276-0128

Center for Drug Evaluation and Research:

Leah Ripper, Ph 301-796-1282, FAX 301-796-9717
Peter Rickman, HFD-610, Ph 301-827-5846, FAX 301-827-5911
Karen Takahashi, Ph 301-796-3191, FAX 301-847-8741

Center for Food Safety and Applied Nutrition:

John Welsh, Ph.D., HFS-205, Ph 301-436-1292, FAX 301-436-2972
Andrew Zajac, Ph.D., HFS-265, Ph 301-436-1267, FAX 301-436-2972

Center for Veterinary Medicine:

George Prager, HFV-234, Ph 240-276-9237, FAX 240-276-9241
Vernon Toelle, HFV-234, Ph 240-276-9238, FAX 240-276-9241
Fredda Valenti, HFV-234, Ph 240-276-9236, FAX 240-276-9241

Office of Regulatory Affairs (ORA)

LuAnn Pallas, R.Ph., HFC-230, Ph 240-632-6849 FAX 240-632-6861 (For ORA and Office of the Commissioner)

Page reformatted: 11-2005