FDA has authority over the formulation, manufacturing, labeling, marketing, promotion and import and export of OTC drugs in the US, and the Consumer Product Safety Commission also sets rules for them. This 90-minute OTC drug regulation training covers what you need to develop and sell an OTC product.
You'll compare the four pathways to market: following a drug monograph, an approved NDA, the Rx-to-OTC switch process, or an ANDA citing an approved product. You'll also learn how to navigate a monograph, judge ingredient safety categories and tell a potential Rx product from an OTC drug.
The session covers claims, cGMPs, tamper evidence and poison control, compliant labels, branded and generic products, and marketing strategies that limit enforcement risk.
OTC products face both FDA and CPSC requirements, and missteps in pathway, labeling or promotion can lead to enforcement action. This session explains your options and how to reduce that risk, including market differences between Rx and OTC products.
It suits regulatory, compliance, quality, marketing, product, labeling, R&D and document control staff, plus senior managers and business owners.
OTC products face both FDA and CPSC requirements, and missteps in pathway, labeling or promotion can lead to enforcement action. This session explains your options and how to reduce that risk, including market differences between Rx and OTC products.
It suits regulatory, compliance, quality, marketing, product, labeling, R&D and document control staff, plus senior managers and business owners.
Dr. Loren Gelber
Dr. Loren Gelber has worked in the pharmaceutical industry for more than 40 years, at both the FDA and in private industry. She has prepared more than 50 submissions to the FDA. Her specialty is compliance with US regulatory requirements. She has a BA in Biology, an MS in Chemistry and a Ph.D. in Medicinal Chemistry.
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