Dr. Neha Patel's practice focuses on advising the pharmaceutical, medical device, and biotechnology industries on a variety of regulatory, enforcement, and compliance matters. She routinely counsels clients on the development and regulation of prescription, over-the-counter, and dietary supplement products, including associated promotional review matters, premarket approval and clearance strategies, and reimbursement and coverage considerations. Dr. Patel assists various life sciences companies and healthcare entities in becoming compliant with the Federal Food, Drug, and Cosmetic Act. She also advises clients on the regulations of medical device software and healthcare IT.

Prior to joining the firm, Dr. Patel gained extensive clinical experience counseling patients on various prescription, over-the-counter, and dietary supplement products as well as submitting coverage claims to insurers in the hospital and community pharmacy setting. Dr. Patel is currently a registered pharmacist in Maryland. During law school and pharmacy school, Dr. Patel interned at the FDA on multiple occasions, including at the Office of Policy, CDER Office of Compliance, and the Office of Special Health Issues, the Generic Pharmaceutical Association (GPhA), and the American Society of Consultant Pharmacists (ASCP). She has also worked as a research associate developing reference standards at the United States Pharmacopoiea (USP) and studying the role of various protein pathways in tumor growth at the National Institutes of Health.

Experience

  • Pharmaceutical and medical device companies in conducting an analyses of FDA and fraud and abuse regulatory issues relating to premarket and postmarket promotion of products.
  • Medical device manufacturers with advice regarding 510(k) and PMA premarket strategies.
  • Pharmaceutical manufacturers and trade associations on comments to proposed FDA and CMS rulemakings.
  • Medical device manufacturers on the regulation of health apps as mobile medical apps.
  • Various pharmaceutical clients on obtaining coding, coverage, and payment for their products and services.
  • Pharmaceutical and biotechnology companies on the regulation of biosimilar and interchangeable biologics under the Biologics Price Competition and Innovation Act of 2009.
  • Various pharmaceutical clients on premarket strategies for novel products.
  • New and established healthcare entities and clinical laboratories in structuring compliance policies and programs.

Credentials

Education
  • JD, University of Maryland Francis King Carey School of Law, 2015
  • PharmD, University of Maryland School of Pharmacy, 2015, summa cum laude
Admissions
  • District of Columbia
  • Maryland
Overview

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