FDA Regulation for Over-the-Counter (OTC) Drug Products Webinar: Explore Key Aspects Such As Regulatory Frameworks, Approval Processes, Labeling Requirements, and Compliance Considerations

Dublin, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The "FDA Regulation for Over-the-Counter (OTC) Drug Products (Aug 22, 2025)" training has been added to ResearchAndMarkets.com's offering.

This 90-minute webinar provides a comprehensive overview of the FDA's regulation of Over-the-Counter (OTC) drugs, covering key aspects such as regulatory frameworks, approval processes, labeling requirements, and compliance considerations.

Participants will gain a clear understanding of the regulatory requirements governing OTC drugs, including the OTC Monograph System, labeling guidelines, and compliance with current Good Manufacturing Practices (cGMP). The webinar will explore the differences between OTC Monograph submissions and New Drug Applications (NDA), as well as the timeline and requirements for OTC drug approval.

Additionally, participants will learn about important considerations for OTC drug development, including nonclinical and clinical studies, establishing product safety and efficacy profiles, and ensuring clear and accurate communication with consumers through labeling and marketing. Compliance and enforcement aspects, including FDA inspections and common compliance issues, will also be discussed. By attending this webinar, participants will gain practical insights and strategies to navigate the regulatory landscape effectively and ensure compliance with FDA regulations for OTC drug products.

Why You Should Attend

This training offers numerous benefits for professionals involved in the development, manufacturing, regulatory affairs, and marketing of Over-the-Counter (OTC) drugs. Attendees will gain a comprehensive understanding of the FDA's regulatory requirements governing OTC drugs, including the OTC Monograph System, labeling guidelines, and compliance with current Good Manufacturing Practices (cGMP).

By mastering key concepts such as the OTC drug approval process, participants will be equipped to navigate regulatory pathways effectively, ensuring timely market entry and compliance with FDA regulations. Additionally, attendees will learn about important considerations for OTC drug development, including nonclinical and clinical studies, product safety and efficacy evaluation, and communication strategies for consumers. Compliance and enforcement aspects, such as FDA inspections and common compliance issues, will also be covered, enabling participants to mitigate risks and maintain regulatory compliance throughout the product lifecycle.

This training is ideal for professionals in regulatory affairs, product development, quality assurance, clinical research, legal, and marketing roles within the pharmaceutical and healthcare industries who seek to enhance their understanding of FDA regulations for OTC drugs and ensure successful market entry and compliance with regulatory requirements.

Who Should Attend:

Quality Assurance DepartmentsQuality Control DepartmentsRegulatory Affairs DepartmentsResearch and Development DepartmentsManufacturing DepartmentsEngineering DepartmentsOperations DepartmentsProduction DepartmentsLabeling ExpertsMarketing DepartmentsCompliance DepartmentsClinical Affairs DepartmentsProduct Development Teams

Key Topics Covered:

Regulatory Framework for OTC Drugs

Overview of the Federal Food, Drug, and Cosmetic Act (FD&C Act)FDA's OTC Drug Monograph SystemLabeling requirements for OTC drugsCompliance with current Good Manufacturing Practices (cGMP)

OTC Drug Approval Process

Differences between OTC Monograph submissions and New Drug Applications (NDA)Timeline and requirements for OTC drug approvalPost-market surveillance and reporting obligations

Key Considerations for OTC Drug Development

Active ingredients and OTC monographsOTC drug categories and therapeutic classesNonclinical and clinical studies requirementsEstablishing product safety and efficacy profiles

Labeling and Marketing Requirements

OTC drug labeling guidelinesDrug Facts Label format and contentCompliance with advertising and promotional materialsEnsuring clear and accurate communication with consumers

Compliance and Enforcement

FDA inspections and audits of OTC drug manufacturersCommon compliance issues and enforcement actionsStrategies for maintaining compliance with FDA regulations

Resources and Support for OTC Drug Manufacturers

FDA guidance documents and resourcesIndustry associations and collaborative initiativesTraining and educational opportunities for OTC drug professionals

Speaker

Meredith Crabtree has over 30 years' experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health. This includes manufacturing, packaging, labelling and distribution operations. Meredith is the owner of MLKC Consulting is s a Quality Consultant specializing in product label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings.

For more information about this training visit https://www.researchandmarkets.com/r/zic7ow

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