Becca McKnight advises clients who develop, make and distribute FDA-regulated products and who play a part in the investigation and delivery of healthcare products and services.

She provides 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 FDA experience spans a wide range of products, with an emphasis on medical device, pharmaceutical and biological drug regulation and compliance.

Her work has also focused on potential compliance matters, under the Anti-Kickback Statute, Sunshine Act and other 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 healthcare law with "big data" business models, addressing regulatory and compliance considerations for the collection, sharing and use of patient and product information.  

Her advice is frequently sought in connection with 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.