Becca 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
  • Liaising and collaborating with counsel in Europe, Asia and Latin America to provide coordinated regulatory advice and strategic assistance to global pharmaceutical and medical device companies
  • Advising on state-level licensure and compliance requirements for manufacturers, distributors, pharmacies and compounders
  • Conducting internal investigations and assessments of regulated companies and entities in the areas of product promotion, adverse event reporting, notifications and filings triggered by product changes, data integrity, Good Manufacturing Practices, Good Clinical Practice and fraud and abuse
  • 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
  • Advising clients in the medical technology space, including developers of a variety of apps and algorithms, in light of FDA's evolving regulatory approach over the past several years
  • Conducting due diligence on FDA-regulated 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
  • 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 healthcare facility license and certificate of need issues for non-traditional healthcare establishments
  • Advising on CLIA issues, including the interplay of CLIA and FDA law governing diagnostics