Javier O. González-Rivera

Javier González-Rivera assists clients on a broad range of life sciences matters including regulatory, compliance, enforcement and transactional matters. His clients include pharmaceutical and medical device manufacturers, healthcare providers and food and cosmetic companies. Mr. González-Rivera’s practice focuses on issues related to FDA regulation of drugs, medical devices, food, and cosmetics, as well as ensuring compliance with FDA and FTC advertising and promotion requirements for consumer products.

Javier received his JD, magna cum laude, from the University of Puerto Rico School of Law where he founded the Health Law Pro Bono program and participated in the Intellectual Property and Emerging Technologies Clinic. He also possesses an LL.M. from Georgetown University Law Center, with highest honors, where he completed a certificate in Food and Drug Law, and served as Senior Editor for the Food and Drug Law Journal. He currently serves as Vice Chair for the ABA’s Life Sciences Committee and is a member of FDLI’s Medical Device Committee.

He received his Bachelors of Science from Emory University in Neuroscience and Behavioral Biology.

• Counseling on the resolution of FDA enforcement and investigative actions, including Form FDA-483 observations and Warning Letters
• Advising on clinical trial compliance for drug and medical device products, including clinical trial agreements, patient informed consents, adverse event reporting and product promotion
• Advising consumer healthcare companies on FDA, FTC and NAD advertising compliance, including labeling, website and social media reviews. Advising on substantiation criteria and developing approaches to developing compliant advertising campaigns
• Conducting regulatory due diligence on behalf of regulated companies and potential investors in connection with commercial transactions involving food and life sciences companies
• Advising various pharmaceutical and medical device manufacturers on best practices for compliant activities around the use of promotional and medical materials
• Assisting various major cosmetic companies conduct product recalls from market, including up to FDA close out
• Analyzing legislation, regulations, and guidance for industry and advising FDA-regulated companies on the implications of these developments
• Assisting clients on compliance with the Drug Supply Chain Security Act (DSCSA) and Compounding Quality Act