This primer will provide attendees with an essential an in-depth working knowledge of the cornerstone laws and regulations applicable to the production, marketing and distribution of OTC drugs.

Topics addressed during this workshop will set the stage for the main conference by helping you to thoroughly comprehend the complexities and challenges associated with the laws, regulation and governance of OTC drug and consumer health products in the United States.

Topics to be covered will include:

• Defining OTC drug products
• Drugs vs. cosmetics vs. supplements
• Cosmeceuticals vs. nutraceuticals
• Demystifying the laws and regulations governing OTC drugs
• Exploring the criteria for OTC drug products
• Safety, efficacy, self-diagnosis, self-treatment
• Comparing and contrasting OTC drugs vs. Rx drug products
• Examining the role and authority of FDA in the U.S. OTC market, including analyzing the interplay between the various offices within the FDA
• CDER’s Office of Nonprescription Drug Products
• The Office of Drug Evaluation IV (ODE IV)
• Office of New Drugs
• Nonprescription Drug Advisory Committee
• Understanding the Journey of an OTC Drug to Market
• If it’s a new drug
• If it’s not a new drug
• Rx-to-OTC switch
• Determining how the OTC Drug Review process is established in the United States
• Identifying which drugs are covered under the OTC Drug Review process
• The monograph system
• Monographs vs. NDAs
• When is an NDA or ANDA used in the OTC process?
• What information does a monograph contain?
• What if you want to deviate from the monograph and innovate?
• The significance of the label
• What information must an OTC label contain
• OTC advertising and promotion fundamentals and examining FTC’s and NAD’s role in the space