Clinical Trials, FDA and Research

Mintz Levin provides regulatory and strategic advice to companies subject to the laws of the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) of the Department of Health and Human Services, and other state and federal laws governing basic, pre-clinical and clinical research. Our clients include pharmaceutical, biotech, medical device, cosmetic, and dietary supplement companies, and range in size from small start-ups to established Fortune 500 companies, foreign manufacturers, and trade associations. We also counsel investment banks and private equity and venture capital firms in connection with public and private stock offerings and mergers and acquisitions involving FDA-regulated companies, as well as academic medical centers and research staff who participate in sponsored clinical research or initiate their own studies.

Working with our colleagues in Mintz Levin’s intellectual property, corporate and licensing, securities, antitrust, tax, and litigation practices, we provide integrated, practical advice on successful product development and marketing. We guide clients through the preclinical and clinical phases of product development through to product approval and launch. We also counsel them on preparing for and progressing through the Institutional Review Board (IRB) and Stem Cell Research Oversight Committee (SCRO) review processes.

Our experience includes counseling clients on:

• all aspects of clinical trials, including clinical trial agreements and arrangements with contract research organizations and other service providers
• drafting informed consent forms and HIPAA authorizations
  
• access to and use of tissue and associated patient information in connection with research
  
• research involving human cellular and tissue-based products
  
• regulatory and compliance issues related to the development and offering of clinical laboratory tests
  
• regulatory and reimbursement due diligence review of a wide variety of drug and medical devices companies, contract research organizations, and independent laboratories
  
• responses to FDA inspections (483s), Warning Letters, and other compliance-related communications
  
• compliance and enforcement actions before various agencies, including the FDA, Federal Trade Commission, Drug Enforcement Administration, Department of Justice, and state attorneys general
  
• evaluation of approval pathways, including those for combination products
  
• labeling, advertising, and promotional issues
  
• the content of press releases announcing regulatory and clinical developments and reporting disclosures in SEC-required filings.

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