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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. This includes:
- Senior Managers / Business Owners
- Product Managers
- Labeling and Artwork Designers
- Regulatory and Quality Professionals
- Sales and Marketing Managers
- R&D Managers and Staff
Use coupon code NB5SQH8N and get 10% off on registration.
There may be many networking opportunities at the Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations (Updated to address recent Homeopathic Drug announcements by FDA & FTC). Find out more in the event details below.
|Conference/Event Dates:||05/16/2017 - 05/17/2017|
|Conference/Event Hours:||8:30 AM to 12:30 PM|
|Primary Industry:||Clinical Pharmacology|
|Other Industries:||Business, Clinical Pharmacology, Manufacturing, Marketing, Medical, Professional Healthcare, Sciences|
|Cost to Attend:||One Registration - $1699|
|Audience:||Senior Managers / Business Owners
Labeling and Artwork Designers
Regulatory and Quality Professionals
|Booth Size||Booth Cost||Available Amenities|
|Call for information.||Electricity:||n/a|
|Marketing Vehicles Allowed:||Call|
|Other Booth Sizes Available: n/a|
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