Senior Pharmacologist/Toxicologist
Food and Drug Administration
Owen McMaster has more than 20 years’ experience helping to create nonclinical and regulatory strategies for developing drug products at the FDA. He is currently a senior pharmacology/toxicology reviewer with experience working with multiple technical subcommittees and the Education subcommittee at the Center for Drug Evaluation and Research. He is responsible for providing nonclinical and regulatory strategic advice to biopharmaceutical companies seeking to advance complex development programs for therapeutics intended to treat a wide variety of diseases, which include serious conditions under IND and marketing applications. Across his career, he served as a thought leader on the assessment, communication, and management of risks related to various types of products (e.g., small molecules and biologics) and the individual components of them. These experiences have allowed him to make numerous presentations at international meetings on topics that include the use of drugs with abuse potential such as cannabis and its chemical constituents cannabinoids as therapeutics.
Disclosure information not submitted.
Considerations for Cannabidiol Product Development: The Regulatory Landscape and Safety Concerns.
Thursday, October 5, 2023
8:00 AM – 9:15 AM EDT