Overview
Chambers USA
Whether you’re a global biopharma leader in medical devices and drugs, a cutting-edge digital health innovator, a clinical research organization or something completely new, McDermott’s Food and Drug Administration (FDA) practice will help fuel your mission by guiding you through the complex regulatory and compliance landscape.
As the top-ranked law firm for health and a leader in life sciences, we are dedicated to our clients and passionate about the work we do together. We counsel clients on the development, manufacture, marketing and promotion, and reimbursement of drugs, biologics, devices and other products regulated by the FDA.
Led by a former US Food and Drug Administration (FDA) Associate Chief Counsel and a former senior executive in-house counsel to leading biopharmaceutical companies, our FDA regulatory lawyers offer deep industry experience, strategic legal advice, diverse perspectives and practical solutions that address the full scope of regulatory and compliance issues life sciences companies face.
Our cross-border, cross-practice team will work collaboratively to help you clear your path to success on issues such as intellectual property, data privacy and security, litigation, pricing, reimbursement and healthcare compliance. We advise clients on the following:
- Current Good Manufacturing Practice (cGMP), Medical Device Quality System Regulation (QSR), Good Clinical Practice (GCP), internal compliance programs, internal and external audits, and standard operating procedures (SOPs)
- Marketing applications and other regulatory submissions, product labeling, advertising and promotions, and post-market surveillance
- Product regulatory status determinations, import-export compliance, and other pre- and post-market regulatory programs
- FDA inspection preparedness and responses to FDA Inspectional Observations (483s), warning letters and other regulatory communications
- FDA investigations, FDA consent decrees and other enforcement actions involving the FDA, the US Department of Justice (DOJ), state attorneys general, other federal and state agencies, the US Congress, and False Claims Act qui tam and other litigants
- Compliance program implementation, auditing and monitoring in accordance with OIG’s Seven Elements of an Effective Compliance Program and applicable PhRMA Code/ADVAMED industry standards and applicable laws and regulations
- Development and submission of citizen petitions, trade complaints and comments on FDA proposed rules and guidance
- Entry into the United States of non-US companies through clinical-study, approval, prelaunch, compliance-program and other initiatives
