Fda Guidance Regarding Clinical Trials For Foods, Food Ingredients, And Dietary Supplements

Description:There has been an explosive growth in the market for dietary supplements, both in terms of expansion of range of products and increase in number of people using them. In a high growth market in which processes and results are subjective in contradiction to the hairsplitting exactness required of pharma products there is scope for spurious and unverifiable claims over the purported benefits of several dietary supplements.
Regulation of this industry lies beyond the purview of the FDA. So, it can only offer recommendations and not set stringent standards for dietary supplements. It works in conjunction with the Federal Trade Commission (FTC) to ensure that manufacturers and distributors are up to date with the requirements for product labeling and acceptable marketing claims. The FDA is likely to become more actively involved in framing more stringent regulations about this industry in the future. This webinar will examine the existing recommendations from these bodies.
It will take up two important guidance documents on this issue, namely “Dietary Supplements: An Advertising Guide For Industry” and “Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act”. The first of these deals with identifying advertising claims and interpreting them; while the second relates to the FDA recommendations to a product manufacturer have to substantiate a claim under section 403(r) (6) of the Act.
When: Tuesday, November 20, 2012 , 10:00 AM PDT | 01:00 PM EDT
By whom:Joy Frestedt, PhD, CCTI, RAC, FRAPS, is the President and CEO of Frestedt Incorporated, a novel virtual Contract Research Organization network of over 50 experts and highly skilled staff meeting specific needs in regulatory, clinical and quality affairs.
Dr. Frestedt has over 30 years of scientific, clinical and regulatory experience in the health care, pharmaceutical and medical device industries especially running clinical trials, conducting laboratory analyses and assisting firms with strategic decisions involving clinical research programs, regulatory strategies and the development of quality systems to compete globally.
Dr. Frestedt holds a B.A. in biology from Knox College and a Ph.D. in pathobiology from the University of Minnesota Medical School. She was named one of the 100 Most Inspiring People in the Life Sciences Industry (by PharmaVOICE, 2011) and one of the top 25 Industry Leaders/ Women in Business Award (by the Minneapolis/St. Paul Business Journal, 2011).
For whom:
The webinar will benefit
oDietary Supplement Manufacturers
oDietary Supplement Distributors
oSales/Marketing Personnel
oPresidents and Executives of Dietary Supplement companies
oManagers of Quality Affairs
Duration: 60 minutes
To enroll for this webinar, contact

Phone: 800-447-9407

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