Louise Howe, a counsel in the firm's FDA Group and a member of the Life Sciences Practice and Privacy and Data Security Practice, concentrates her practice on food and drug law, medical device regulation and data privacy and security regulation.

Ms. Howe represents clients in all phases of FDA regulation, from determining product jurisdiction and obtaining marketing clearances, to responding to FDA compliance actions. In the device area, she has counseled clients in areas including clinical investigations, product labeling and advertising, good manufacturing practices, medical device reporting, and product exports and imports. Ms. Howe has participated in significant petitions to the FDA regarding fundamental agency regulatory mechanisms.

Ms. Howe also provides counsel and assists with due diligence evaluations, in connection with securities filings for FDA regulated companies, and assists with FDA-related litigation. She has provided counsel regarding food additives and dietary supplements, including the labeling and advertising of such products.

As a member of the firm’s Privacy and Data Security Practice, Ms. Howe counsels clients in privacy and data security regulation and compliance, including under HIPAA and state laws. She also counsels clients regarding state and federal requirements applicable to manufacturers’ interactions with health care professionals.