Drug & Device Law

DCBA’s attorneys work collaboratively with pharmaceutical, biotechnology, and medical device manufacturers to maximize their development and commercialization opportunities and advance their corporate-responsibility objectives.

On a day-to-day basis, these activities often translate into painstaking research into federal regulations, guidance, and notices; analyses of potential impacts on patients, providers, payers, and the public; and the development of recommendations to advance the client’s commercial interests and the public interest simultaneously.

  • Corporate strategy development
  • Medical device clearance, approval, compliance, and post-marketing strategies and counsel
    • 513(g) confidential requests for information regarding classification and regulatory requirements
    • Appeals of adverse regulatory decisions
    • Corrections, recalls, and removals
    • De Novo classification requests
    • Establishment registration and product listing
    • Mandatory reporting requirements for manufacturers, importers, and user facilities to report certain adverse events and product problems to the FDA
    • Premarket notification procedures, including submitting a 510(k) to pursue marketing clearance
    • Preparation for advisory committee meetings
    • Product classification and reclassification
    • Product labeling, advertising, and promotion
  • Small molecule and biologic drug development, marketing, and insurance coverage strategy and counsel
    • Analysis and interpretation of biosimilar substitution laws
    • Advisory committee presentations
    • Best practices for working with not-for-profit organizations
    • Coding and payment models for Medicare Part B
    • Controlled substance scheduling analyses, recommendations, and appeals
    • Coverage and benefit utilization management reform among Medicare Part B and Part D programs, commercial insurance, and health systems
      • Adverse tiering
      • Copay accumulator programs
      • Nonmedical switching
      • Oral parity
      • Prior authorization
      • Step therapy
    • Drug distribution and delivery models, including specialty pharmacy
    • Expedited approval
      • Accelerated approval
      • Breakthrough therapy
      • Fast track
      • Priority review
    • Labeling for opioids with abuse-deterrent properties
    • Medical counter measure priority review vouchers
    • Risk Evaluation and Mitigation Strategies (REMS)
    • Statutory and regulatory standards
    • Suspicious order monitoring