Anthony Fanucci
FDA Senior Associate at Alston & Bird | Pharmacist | Passionate about FDA and Pharmacy Law
- Role
- Senior Associate at Alston & Bird
- Location
- Washington, DC, US
- LinkedIn followers
- 500 followers
About Anthony Fanucci
As a pharmacist lawyer, I am fascinated with the intersection of health and the law. Most of my energy is devoted to learning, understanding, and writing about topics from this area of convergence. I have the privilege of serving as an associate on Alston & Bird\'s FDA Team in Washington, DC.
Experience
Senior Associate
Jul 2021 — Present · Washington, DC, US
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.
Education
Wilkes University
Doctor of Pharmacy - PharmD, Pharmacy
2012 — 2018
Penn State Dickinson Law
Doctor of Law - JD, Law
2018 — 2021
Skills
- Customer Service
- Teamwork
- Communication
- Leadership
- Event Planning
- Work Ethic
- Microsoft Excel
- Social Networking
- Money Management
- Public Speaking
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.