- Advised foreign and domestic drug and drug substance manufacturers regarding FDA facility inspections, warning letters, untitled letters, requests for information, and regulatory meetings, including on-site work in India.
- Advised drug and drug substance manufacturers on developing concerns regarding nitrosamines, benzene, and other genotoxic impurities. This work has included the analysis of de-risking plans for sites making manufacturing changes related to impurities.
- Guided clients with their development of corporate-wide control strategies for nitrosamines and other genotoxic impurities, including the mitigation of nitrosamine drug substance-related impurities (NDSRIs).
- Assisted a national dermatology practice to assess the requirements under a REMS program and advocate on behalf of prescribers facing penalties for alleged non-compliance with such requirements.
- Conducted a holistic review of drug, food, waste, and chemical permits for multiple clients and detailed CHOW requirements for all permits in advance of equity sales.
- Assisted clients on multiple DEA matters, including navigating DEA’s controlled substance quotas and telehealth flexibilities.
- Helped guide a medical device startup with the importation and distribution of FDA-authorized COVID-19 antigen tests under COVID-19-modified state licensing requirements to fulfill critical needs.
- Helped a prescription medical device manufacturer and distributor navigate state requirements in states with jurisdiction over medical devices vs. states that do not regulate or license medical device establishments.
- Assisted a product delivery company by analyzing state regulatory requirements for the delivery of cannabis-derived products and recommending an operational strategy that minimized enforcement risks.
- Drafted a legal opinion emphasizing the inapplicability of a state’s medical device distribution regulations, which enabled the client to continue its activities in the state in question.
执业律师,
Anthony, a licensed pharmacist, relies on his pharmacy background and experience as a pharmaceutical licensing consultant to guide FDA-regulated clients through regulatory and enforcement actions.