Devaki (Devki) Patel is an associate with Foley & Lardner LLP, based in the firm’s Washington D.C. office, where she is a member of the firm’s Government Solutions and FDA Regulatory Practices. She is also a member of the Life Sciences, Food and Beverage and Cannabis Industry Teams. In addition to being an attorney, she is a licensed pharmacist.
Prior to joining Foley, Devaki worked for the Food and Drug Administration as a legal intern, where she gained experience drafting and reviewing decisional documents for compliance with the Federal Food, Drug and Cosmetic Act (FDCA), FDA regulations, FDA guidance documents and precedent with respect to the filing and approval of Abbreviated New Drug Applications (ANDAs). She prepared internal memoranda analyzing ANDA-specific issues for the regulatory team and drafted responses to reconsideration requests related to filing of ANDAs involving stability data and bioequivalence. She also prepared regulatory responses to ANDA suitability petitions and citizen petitions received from pharmaceutical firms as well as assisting with projects related to Hatch-Waxman issues (e.g., 180-day exclusivity and forfeitures) and labeling carve-outs covered by an exclusivity.
While in law school, Devaki also served as a legal intern at FDA’s Office of Policy at the Center for Devices and Radiological Health. In addition, Devaki’s education and professional career in pharmacy allows her to understand an array of pharmacy-related matters, including Drug Enforcement Administration requirements, pharmacy compounding, reimbursement, and pharmacy benefit managers (PBM) regulations.