These half hour webinars are designed to provide an educational overview of OTC regulatory requirements, key marketing issues, and FDA enforcement in this area.
1. Over-the-Counter Drug Product Monographs: What you need to know, focused on the basics of OTC drug products, homeopathics and the key differences between the two.
2. Over-the-Counter Drug Monographs: FDA Requirements for Hand Sanitizers & COVID-19-focused products, looked closely into COVID-19 temporary policies, permanent policies moving forward as the pandemic comes to a close and OTC facility fees.
3. Over-the-Counter Drug Product Monographs: FDA Requirements for topical products, will focus on helping companies who produce over-the-counter topical pharmaceutical products, such as sunscreen, topical acne treatments and more, understand what is required of them to become and stay compliant with the FDA.
4. Over-the-Counter Drug Product Monographs: FDA Requirements for Oral Pharma Products, provided help for companies producing or distributing over-the-counter oral pharmaceutical products such as internal analgesics (i.e. ibuprofen), oral healthcare products, cold, cough and allergy products and more, understand what is required of them to become and stay compliant with the FDA.
5. Over-the-Counter Drug Product Monographs: FDA Requirements for Homeopathic Products, provides guidance for companies who produce homeopathic products, including those with ingredients derived from plants, healthy or diseased animal or human sources, minerals, and chemicals. As FDA regulation of homeopathic products has changed over the years, we will provide an overview of FDA risk-based enforcement approach.
6. Over-the-Counter Drug Product Monographs: Cosmetics and Other Combination Focus. In this webinar, the speakers provided FDA regulatory guidance for companies who produce cosmetic and drug combination products, including moisturizers marketed with sun-protection claims, antidandruff shampoos marketed to both cleanse and treat dandruff, toothpaste marketed with fluoride, etc