Food, Drug & Medical Device Regulatory

Overview

McDermott’s US Food and Drug Administration (FDA) practice provides comprehensive regulatory and strategic advice to pharmaceutical, biotechnology, medical device, dietary-supplement and food companies, as well as digital-health technology developers and clinical research organizations. We counsel clients on the development, manufacture, marketing and promotion, and reimbursement of drugs, biologics, devices and other products regulated by the FDA.

Our lawyers are nationally recognized as leading lawyers in FDA law by US News-Best Lawyers and LMG Life Sciences and offer industry experience, practical solutions and diverse perspectives to address complex problems facing life sciences companies. Members of our team have worked at FDA in legal and regulatory positions and held senior legal and compliance roles in pharmaceutical and biotech companies.

Our broad experience allows us to benchmark and characterize industry trends to provide thoughtful and practical risk assessments and strategic advice. Our lawyers focus on a variety of legal issues, including manufacturing and quality, advertising and promotion, clinical research, diagnostic testing and post-market compliance.

We leverage our global platform and complimentary practices to provide interdisciplinary advice to our life sciences clients on issues such as intellectual property, data privacy and security, litigation, pricing, reimbursement and health care 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

Key Contacts

Results

Advising the digital health business unit and regulatory team of one of the world’s leading independent biotechnology companies on FDA regulatory matters related to the development of digital health solutions, including mobile applications and software; we help the company evaluate regulatory pathways for innovative products to enter the market, manage post-market compliance issues for new products that combine biopharmaceuticals, digital technology and health IT solutions, and address related issues on the cutting edge of personalized medicine and innovative therapies
Advising a global genomic-based clinical laboratory services company in the development and implementation of government strategies to address FDA regulatory and Medicare reimbursement issues for their laboratory tests, including advising on compliance and fraud and abuse issues in the current environment of heightened scrutiny
Advising a biopharmaceutical and medical device company and its research and development arm on a range of regulatory issues related to the development and marketing of drugs and medical devices
Advising a global technology company on its FDA regulatory strategy for innovative software and hardware solutions for a range of therapeutic applications, providing counsel on product marketing, and assisting with the establishment of regulatory systems and infrastructure to support new and emerging products and business units
Advising a global leader in the mobility device industry on FDA regulatory issues related to the classification and marketing strategy for its innovative upper and lower limb products, including helping the company to evaluate current Good Manufacturing Practice (cGMP)/Quality System Regulation (QSR) requirements in light of recent updates to global device quality and manufacturing standards announced by European regulators
Assisting a global life sciences company with clinical development, regulatory strategy, marketing, supply chain and patient-engagement programs, and advising on a variety of regulatory and compliance issues, including the development of policies and procedures for the distribution of pharmaceutical products