Resources
Resources to help build a stronger science-based community.
Our Publications
Based on years of research, the Frestedt Incorporated team publishes numerous books, articles and clinical trial documents. If you need help dealing with (or avoiding) an FDA warning letter or if you are struggling with clinical evaluations or safety reporting for your drug, device or food product, please contact us. We’re here and ready to help!



Navigating Temporary Use Authorizations: Face Masks
Link to download PDF

Standard Operating Procedure COVID-19 Clinical Study at an Investigational Site
Link to download PDF

Frestedt Incorporated: One-Stop-Shop for Clinical, Regulatory, Quality, and Engineering
Link to article on Pharma Tech Outlook

FDA Warning Letters About Food Products How to Avoid or Respond to Citations
Full length book by Dr. Joy Frestedt. Link to buy book

GRAS from the ground up: Review of the Interim Pilot Program for GRAS notification
Paul R. Hanlon, PhD, DABT , Joy Frestedt, PhD, CPI, RAC, FRAPS , Kelly Magurany, MSc, DABT Link to publication

Warning Letters – 2016 Reference Guide
Full length book by Dr. Joy Frestedt. Link to buy book With Food and Drug Administration becoming more involved with

Meal Replacement Beverage Twice a Day in Overweight and Obese Adults (MDRC2012-001)
Frestedt JL, Young LR, Bell M Link to publication Download the PDF

Starting a Clinical Research Program: Is it a natural evolution to your practice?
Wolfe PJ, Frestedt JL Link to publication