Edgar Asebey is a life sciences regulatory and transactional attorney with over 20 years of experience advising clients in the pharmaceutical, biotechnology, biologics, medical device, food, and dietary supplement industries on FDA regulatory compliance and FDA regulatory matters, including licensing, transactional, and venture finance issues.

Edgar represents clients before the U.S. Food and Drug Administration (FDA), the United States Department of Agriculture (USDA), U.S. Customs and Border Protection (CBP), the U.S. Federal Trade Commission (FTC), the U.S. Environmental Protection Agency (EPA), the National Institute for Occupational Safety & Health (NIOSH), and the Drug Enforcement Agency (DEA), providing compliance and enforcement defense services before these agencies. He assists client companies with registration, clearance, and pre-market approval applications to the FDA and advises on compliance matters associated with the development, manufacture, marketing, and sale of FDA-regulated products.

He counsels clients and performs regulatory due diligence in support of venture financings, public offerings, and M&A transactions. He also advises emerging life science and psychedelic drug development companies on patent portfolio development, FDA regulatory and clinical trial strategies. Since 2016, he has been advising cannabis and hemp companies and currently provides regulatory compliance, due diligence, and transactional advisory services to hemp/CBD, cannabis/marijuana, and psychedelics biotechnology companies. In addition to his legal practice, Edgar is a founding member and the FDA regulatory advisor to the Iter Investments Fund, a venture capital firm focused on supporting emerging psychedelic biotech companies.

Early in his career, Edgar served as Patent and Licensing Advisor to the Natural Products Branch of the National Cancer Institute (NCI) at the National Institutes of Health (NIH). He then founded and served as president and CEO of Andes Pharmaceuticals, Inc., a natural products biotech company, from 1995 to 2000. Edgar has served as in-house counsel to two life sciences companies and was later an equity partner in the Health Care & Life Sciences Practice Group at Jones Day. In 2016, he established Keller Asebey Life Science Law, PLLC, the immediate predecessor to Asebey Life Science Law.

Representative Matters

• Responded to FDA Warning Letters and 483s on behalf of numerous dietary supplement and food clients, ensuring FDA compliance.
• Successfully removed a major Chilean salmon company from an FDA Import Alert, demonstrating strong FDA regulatory expertise.
• Represented a U.S. company in a Prop 65 action related to the company’s beverages, navigating complex compliance issues.
• Assisted a European company in creating a dossier for a New Dietary Ingredient Notification (NDIN) submission to the FDA, ensuring full regulatory compliance.
• Negotiated and drafted licensing, purchase, and distribution agreements for various food companies in the U.S., Japan, and Latin America, with a focus on FDA regulatory requirements.
• Managed a food recall for dietary supplement, human, and pet food companies, addressing critical FDA compliance challenges.
• Assisted a psychedelics biotech company in preparing for a pre-IND meeting with the FDA, guiding them through the FDA regulatory process.
• Performed label, advertising, and social media review for cannabinoid, Kava, and Kratom-containing beverages, ensuring FDA compliance and adherence to advertising regulations.
• Conducted regulatory due diligence on a French pharmaceutical company in connection with its sale to a U.S. private equity firm, focusing on FDA regulatory standards.
• Advised a U.S. biopharmaceutical company on the potential sale of option rights to a pediatric priority review voucher (PRV), incorporating FDA regulatory considerations.
• Performed regulatory and IP due diligence on various psychedelic biotech ventures on behalf of a U.S. venture capital fund, ensuring full FDA compliance.
• Provided regulatory compliance services to a $2.4 billion hospital group on FDA and state healthcare laws governing the commercialization of de-identified human solid and liquid tissue.
• Advised and negotiated on behalf of a European API manufacturer a $94 million IP licensing and supply agreement with a prominent U.S. medical foods company, ensuring FDA regulatory adherence.
• Negotiated an IP licensing agreement and sponsored research agreement between a biotech client company and Brigham and Women’s Hospital/Harvard University, navigating FDA regulatory requirements.
• Advised a Brazilian biologics company on the §351(k) pathway for licensing a biosimilar, focusing on FDA regulatory compliance.