Biography

JAMES A. BOIANI is a Senior Counsel in the Health Care and Life Sciences practice, in the firm's Washington, DC, office. He has extensive experience in FDA legal and regulatory matters, having worked with large and small medical device and drug companies (including many in vitro diagnostic companies) and trade associations in the life sciences industry on a variety of FDA-related issues. His practice focuses on the following:

  • 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
  • FDA product approval and clearance process
  • FDA regulatory issues and opportunities in product development
  • Combination products and companion diagnostics

Mr. Boiani's experience includes:

  • Assisting companies in pre-enforcement situations by helping them manage FDA inspections; working on responses to FDA-483 observations, untitled letters, and warning letters; developing and implementing remediation strategies to correct compliance issues; and advising clients on handling difficult FDA compliances issues more generally
  • Advising clients on adverse event (AE) and medical device report (MDR) reporting, recalls, and associated issues; of recent note, Mr. Boiani has served as the primary outside legal advisor to a major medical device company for more than over two years, providing extensive support on all facets MDR reportability, recall decisions, recall communications to customers, recall reports to regulatory agencies and associated agency communications, and recall-related issues (such as root cause investigations and CAPAs), from both a case-specific and global corporate policy standpoint
  • Helping companies address advertising and promotional issues, including the review of promotional pieces, policy development regarding off-label uses and associated issues (e.g., handling unsolicited requests for off-label information and good reprint practices), the development of communication strategies, and conducting intensive advertising and promotional trainings for marketing and sales, scientists, and management
  • Representing and counseling clients in FDA drug, medical device, and biological approval- and clearance-associated matters, such as application submissions (i.e., NDAs, BLAs, ANDAs, PMAs, and 510(k)s), responses to FDA complete response/deficiency letters, administrative appeals of adverse FDA decisions, clinical and nonclinical trial design issues, and complex 505(b)(2) and combination drug policy issues
  • Counseling clients on issues regarding combination products (e.g., cGMPs, registration, and listing) and the development of companion diagnostics, and supporting policy initiatives of trade associations in the area of companion diagnostics
  • Representing medical device manufacturers in matters involving CLIA waivers
  • Advising drug developers on lifecycle management issues and opportunities
  • Assisting pharmaceutical and biotechnology firms in obtaining pediatric market exclusivities, Hatch-Waxman exclusivities, and patent term extensions
  • Representing clients in matters involving drug and medical device development (i.e., IND and IDE issues) and other pre-approval and pre-clearance issues (e.g., Emergency Use Authorizations)
  • Representing small and start-up biotechnology firms pursuing FDA user fee waivers, and advising clients on user fee issues

Mr. Boiani has also worked for the Veterans Pro Bono Consortium, which provides free legal services to veterans.

Prior to becoming a lawyer, Mr. Boiani earned degrees in chemistry from the Massachusetts Institute of Technology and Cornell University, and worked as an environmental regulatory consultant.

Education

  • George Mason University School of Law (J.D., 2004)
  • Cornell University (M.S., 1998)
  • Massachusetts Institute of Technology (B.S., 1996)

Court Admissions

  • U.S. Court of Appeals for the District of Columbia Circuit
  • U.S. District Court, District of Columbia

Bar Admissions

  • District of Columbia
  • Virginia

Memberships

  • American Bar Association