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Lauren advises companies in the pharmaceutical and medical device spaces on an array of regulatory, compliance, and transactional matters involving the Federal Food, Drug and Cosmetic Act and related laws. Lauren provides regulatory counsel on issues related to medical product development, advertising and promotion, manufacturing, digital health, and clinical trials.
Experience
Regulatory Support
- Regularly counsel pharmaceutical and medical device manufacturers on policies and procedures governing promotional activities and quality activities.
- Frequently evaluate promotional claims and materials for a variety of pharmaceutical and medical device clients.
- Regularly assist medical device manufacturers with preparing for FDA inspections and in responding to FDA Form 483 inspectional observations.
- Advised a medical device manufacturer regarding recall strategy and related regulatory and customer communications.
- Advised software companies and medical device manufacturers regarding the FDA regulatory status of and requirements for digital health products.
- Counseled pharmaceutical companies on clinical trial issues, including those related to clinical trial design and clinicaltrials.gov requirements.
- Advised pharmaceutical and medical device manufacturers and hospital systems on drug and medical device importing and exporting requirements.
- Advised a pharmaceutical company on compliance matters associated with the Drug Supply Chain Security Act.
- Advised pharmaceutical clients and investors on issues related to FDA’s expedited development programs and product exclusivity.
Transactional and Litigation Support
- Routinely perform FDA regulatory diligence for acquisitions of and investments in medical device, pharmaceutical, digital health, contract research, regulatory consulting, and life sciences media companies.
- Routinely perform FDA regulatory diligence for initial public offerings and follow-on offerings of pharmaceutical and biotech companies.
- Frequently advise pharmaceutical and medical device companies in connection with collaboration, licensing, and manufacturing, and distribution agreements.
- Drafted and negotiated quality and pharmacovigilance agreements for contract manufacturing organizations, hospital systems, and pharmaceutical and medical device manufacturers.
- Assisted pharmaceutical and medical device companies with internal investigations related to manufacturing and quality concerns.
- Represented a pharmaceutical manufacturer in Lanham Act litigation alleging false and misleading advertising and unfair competition by a foreign competitor.