This interactive one and a half day seminar is intended to help companies understand the legal definitions of cosmetics, drugs, dietary supplements and why certain labeling statements for non-drug products may cause the agency to consider them new drugs without FDA approval.
Understand FDA regulations and policies regarding manufacturing and labeling of OTC drugs covered by OTC drug monographs (minimal information is provided to contrast the new drug approval process).
Learn the definitions of drug, cosmetic, and dietary supplements.
Obtain tips on how to research FDA’s OTC drug monograph rulemakings.
What labeling other than labels can define a product and cause it to be misbranded as a new drug.
Learn that certain ingredients are safe and suitable for use in both drugs and cosmetics.
Who Will Benefit:
This course is intended for personal care product manufacturers and other businesses that wish to develop and/or market drugs that do not require FDA approval. It will also benefit cosmetic, nutritional, liquid soap and other companies that are considering health related claims for their products, but wish to avoid labeling that would make them new drugs lacking FDA approval. While the emphasis is on topical OTCs, well over half of the presentations are also applicable to OTCs taken internally. It will especially benefit own label distributors and smaller firms that do not have a regulatory professional on their staff.
Use coupon code 232082 and get 10% off on registration.