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FDA & Life Sciences

McGuireWoods’ lawyers represent manufacturers, importers, distributors, sellers, investors, financers, and trade associations across all FDA-regulated products and businesses. They advise clients on FDA law and regulation governing the research, development, manufacturing, distribution, advertising, promotion, and labeling of regulated products including small and large molecule drugs, OTC drugs, HCT/P, stem cells, ingredients and excipients (USP monograph), dietary supplements, foods and beverages, and all classes of medical devices. 

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The team prepares agency submissions for market approval or clearance of regulated products. 

They handle investigations, warning letters, and litigation before federal and state agencies, and advise companies on compliance program design, improvement, implementation and assessment. 

They advise clients on reimbursement and payor issues for drugs and medical devices including GPO contracting; DME, Medicaid/Medicare reimbursement and government price reporting, and “bonafide service agreements”; Inflation Reduction Act price controls: PBM relationships and discount/rebate contracting in compliance with antikickback safe harbors; discounts/arrangements with wholesalers and distributors; and 340B program compliance.  

McGuireWoods’ attorneys also advise clients on state and federal Open Payments compliance (“Sunshine”), as well as state non-Sunshine “transparency” law reporting and compliance (relating to disclosures of product pricing, marketing costs, pre-market notifications, etc.).  

Core Competencies

  • FDA regulatory strategy and filings
  • Product labeling, advertising and marketing
  • Medical affairs and scientific exchange
  • Compliance programs
  • Investigations and litigation
  • Corporate transactions
  • Cosmetics
  • Rx and OTC pharmaceuticals
  • Diagnostics and laboratory tests
  • Digital health
  • Nutraceuticals and dietary supplements
  • Food
  • Sunshine and transparency
  • Clinical studies including IRBs, informed consent compliance, site agreements and CROs
  • Investigations, inspections and warning letters
  • Recalls and product withdrawals
  • Data privacy
  • Intellectual property
  • Cannabis
  • HCT/P and stem cells
  • Medical devices
  • Artificial intelligence
  • Payors, reimbursement, PBMs and 340B
  • Product licensing and partnerships

Our team has broad experience negotiating manufacturing and supply agreements, master service agreements, quality agreements, distribution agreements, strategic partnership arrangements and product licenses on behalf of pharmaceutical companies, medical device manufacturers, CDMOs, specialty chemical manufacturers, radiopharmaceutical manufacturers, and ingredient suppliers including small and large molecule manufacturing, mRNA products, proteins, live biotherapeutics and biological materials, and drug/device combination products (such as pre-filled syringes and auto-injectors).  

McGuireWoods represents a broad spectrum of clients involved in life sciences, including:  

  • Pharmaceutical companies (including small molecule, biologics, injectables, OTC drugs and drug/device combinations)
  • Radiopharmaceutical companies
  • Medical device firms including IVD (in vitro diagnostics) companies
  • CROs (contract research organizations)
  • CDMOs (contract drug manufacturing organizations)
  • CMOs (contract manufacturing organizations) and CSOs (contract sales organizations)
  • Hospitals, universities, academic medical centers and clinical trial networks
  • IND/NDA/BLA/510k/DeNovo Sponsors
  • Manufacturers
  • Pharmacies (traditional pharmacies, specialty pharmacies, telehealth and compounding)
  • Importers, distributors and sellers
  • Patient advocacy and charitable organizations
    Industry associations

How We Help

McGuireWoods advises clients on:  

  • IND, NDA, SNDA, 510(k), de Novo, GRAS and other submissions to the FDA for product exclusivity, fast track or breakthrough designation, PRVs and labeling changes.
  • OTC drug matters including monograph compliance.
  • Legal and regulatory matters affecting CROs, CDMOs/CMOs, radiopharmaceuticals, stem cell treatments, pharmacy compounding, dietary supplements, cannabis and other natural substances, foods, alcoholic beverages, and cosmetics.
  • Product development and clinical development strategies and protocols and labeling, including preparing for and assisting with internal and public FDA meetings (e.g., advisory committee meetings).
  • Drug pricing and reporting, Medicaid and Medicare, private/public reimbursement, IRA, MDRP, BFSF and 340B.
  • Development of pharmacovigilance and risk management programs including risk evaluation and mitigation strategies (REMS), some with elements to assure safe use (ETASU).
  • Marketing and promotion (including advertising, labeling and off-label use), scientific exchange, publications, CME, grants and sponsorships.
  • Pre-clinical and clinical trials design, contracting, IRB and patient consents, and good clinical practices (cGCPs) and good laboratory practices (GLPs) compliance.
  • FDA inspections and responses to FDA form 483s, untitled letters, warning letters, and “Dear Manufacturer” and “Dear Doctor” letters.
  • Recalls, product withdrawals and media relations.
  • Corrective action plans, including negotiation of FDA consent decrees, responses to FDA compliance notifications and identification of key concerns that should be addressed to ensure ongoing compliance.
  • Litigation, including defense of individuals and companies in FDA-related recalls, product detention, seizures, import alerts, subpoenas, injunctions, grand jury investigations, civil actions and criminal prosecutions, and APA litigation at all levels of government.
  • Development and operation of manufacturing and distribution facilities within the United States and overseas in compliance with applicable laws and cGMP regulations, QMSR and ISO.
  • Contracts and program design involving transfers of value to HCPs, payors, wholesalers, distributors and others in compliance with Anti Kickback and False Claims statutes and applicable Safe Harbors.
  • Contracts to address issues relating to HIPAA, data privacy, data breach notifications and remediation in the specific setting of life sciences businesses.
  • Compliance program development, assessment and implementation to align with DOJ and OIG guidance.
  • Establishment licenses, state distribution licensing, Sunshine and state law transparency reporting requirements.
  • SEC offerings and disclosures related to life sciences products and businesses.
  • LDT regulatory strategies.
  • CPT/PLA coding, Medicare coverage determinations, MolDx and other reimbursement for laboratory tests.
  • Federal and state licensing and accreditation.
  • Design of compliant federal grant compliance programs.
  • Direct-to-consumer testing regulatory complexities.
  • Clinical lab contracting.

Transactional Acumen

The McGuireWoods FDA & life sciences team advises life sciences companies, investors and service providers across the full range of transactions, including mergers and acquisitions, debt and equity financings, venture capital, public offerings, licensing, joint ventures, buy/sell agreements, equity plans, employment agreements, confidentiality and noncompete agreements, and related tax matters.

The team’s attorneys apply working knowledge of the FDA, CMS, HRSA and other applicable agencies and rules to life sciences transactions, structuring deals to account for company-specific risks and opportunities. They advise on compliance matters arising in daily operations, strategic planning, and sales and marketing, including federal and state anti-kickback laws, FDA regulations, digital health and cybersecurity, and other rules governing pharmaceuticals, medical devices and other products.

When clients acquire or invest significantly in life sciences operating companies, McGuireWoods often remains engaged to counsel on ongoing regulatory and compliance matters, including federal and state antikickback laws, FDA, CMS and HRSA regulations, and other rules governing the manufacture, sale, distribution, marketing and reimbursement of pharmaceuticals, medical devices, diagnostics and other healthcare products.  

McGuireWoods’ interdisciplinary team comprises lawyers — including former regulators, in-house counsel and science professionals specializing in life sciences — whose skillsets and diverse experience allows them to navigate the often complex and continually changing regulations and guidelines coming from the HHS, OIG, FDA, CMS, HRSA, TTB, DEA, USDA, FTC and state governmental agencies.

Team Leaders

full team