JAMES A. BOIANI is a Member of the Firm in the Health Care and Life Sciences practice, in the firm's Washington, DC, office. He has extensive experience in FDA and CLIA legal and regulatory matters, having worked with large and small medical device companies (including many in vitro diagnostic companies), pharmaceutical companies, clinical laboratories, and trade associations in the life sciences industry on a variety of FDA- and CLIA-related issues.
Mr. Boiani's practice focuses on the following:
- Advising on FDA compliance matters, with an emphasis on current good manufacturing practices ("cGMPs") and quality systems; post-market surveillance and safety reporting; recalls; and advertising and promotion
- Representing clients in the FDA product approval and clearance process (e.g., NDAs, BLAs, PMAs, 510(k)s, and CLIA waivers)
- Identifying and capturing regulatory opportunities in product development and lifecycle management
- Ensuring clinical laboratory regulatory compliance (e.g., CLIA compliance)
