Rebecca Jones McKnight works with clients who develop, make and distribute FDA-regulated products and with those who play a part in the investigation and delivery of health care products and services. She co-chairs DLA Piper's Clinical Trials Working Group for the firm's Life Sciences Sector, which is a Legal 500-recommended, industry-focused practice. Ms. McKnight co-chairs the Health Care Policy and Regulatory Working Group for the firm's Health Care Sector - also recommended by the Legal 500. She is also a contributor to and editor of DLA Piper's Health Care blog, available at www.healthcarelawmatters.com, and its Health Care Enforcement and Compliance blog, available at www.thecomplianceblog.com.

Ms. McKnight assists clients with matters including:

• Analyzing pharmaceutical, medical device, dietary supplement and food company policies, practices and documentation to assess areas of vulnerability under relevant regulatory standards and recommending methods to strengthen compliance efforts
• Tracking and evaluating emerging regulatory requirements with potential impact on FDA-regulated companies and developing strategies for compliance
• Conducting internal investigations and assessments of regulated companies and entities in the areas of product promotion, adverse event reporting, data integrity, Good Clinical Practice, and Medicare and Medicaid compliance
• Reviewing labeling, advertising, promotional materials and product claims for drugs, medical devices, dietary supplements and foods
• Developing strategy and providing advocacy and legal guidance for medical device manufacturers with innovative technologies throughout product development and the clearance/approval process
• Conducting FDA due diligence on target companies and products
• Providing guidance on Good Clinical Practice issues arising in pharmaceutical and medical device clinical trials
• Assisting in the negotiation of Corporate Integrity Agreements
• Advising companies on clinical trial registry and results database requirements and assisting with development of internal policies to facilitate compliance
• Liaising with Latin American counsel regarding pharmaceutical and device issues, including import and marketing authorization requirements, distribution arrangements, and clinical trial issues to provide US clients with comprehensive analysis of the regulatory implications of doing business in foreign jurisdictions
• Advising FDA-regulated entities on registration and listing, adverse event and medical device reporting, recall procedures, FDA import/export issues, Quality System/GMP requirements and promotion and advertising
• Responding to 483 Inspectional Observations and Warning Letters
• Advising life science and food and beverage companies on regulatory and contract issues raised by a variety of partnerships, collaborations and outsourcing relationships
• Preparing Quality Agreements for pharmaceutical and medical device companies and providing advice on GMP compliance, vendor oversight and supply chain risk
• Preparing company policies on handling FDA inspections of food establishments
• Advising companies on FDA regulation of radiation-emitting products (medical and non-medical)
• Providing regulatory counsel and strategic litigation assistance for pharmaceutical companies, as relevant to cases involving failure to warn claims, and addressing allegations related to reporting of adverse events and clinical data and promotional practices
• Assisting companies in assessing litigation risks in connection with FDA-regulated products
• Advising on cross-border issues such as importing research animals, importing animal-derived research materials and import/export of investigational products
• Advising on Federal Trade Commission advertising standards
• Advising on Alcohol and Tobacco Tax and Trade Bureau requirements
• Assessing corporate practice of medicine issues as well as health care facility license and certificate of need issues for non-traditional health care establishments
• Advising on CLIA issues, including the interplay of CLIA and FDA law governing diagnostics

Ms. McKnight began her career as a member of the FDA/Healthcare team at King & Spalding in Washington, DC.