Rebecca Jones McKnight

In recent years, her practice has found increasing focus on legal and regulatory issues connected to the acceleration of the convergence of FDA, health care, and med tech matters.

Becca’s FDA experience spans a wide range of products, with an emphasis on medical device, pharmaceutical, and biological drug regulation and compliance. She works with both established U.S. companies and those looking to enter the U.S. market from around the globe.

Her practice includes strategic regulatory counseling to help clients commercialize products and services and establish and maintain compliant operations. She has extensive experience in developing policies and procedures for FDA and health care compliance; conducting proactive reviews, risk assessments, and internal compliance investigations; and correcting and remediating non-compliance.

Her work has also focused on potential compliance matters, under the Anti-Kickback Statute, the Sunshine Act, and other federal and state laws, raised by relationships between physicians and industry, including those arising in the context of clinical research, product development, and product sales, purchasing, and promotion.

She provides advice on the intersection of clinical trial and health care law, addressing regulatory and compliance considerations for the collection, sharing, and use of patient and product information, including “real world” data and evidence.

Becca also frequently advises on a variety of corporate transactions involving FDA-regulated products and companies, from commercial agreements to M&A transactions to private company financings to IPOs and follow-on offerings.

Becca also serves as managing partner of Reed Smith’s Austin office.