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FDA Regulatory

  • Worked with several Mintz clients operating in non-FDA regulated industries to determine how to manufacture and distribute face shields, face masks, and alcohol-based hand sanitizers in compliance with FDA’s enforcement discretion policies during the COVID-19 pandemic, including by providing promotion and labeling advice.
  • Guided clients developing COVID-19 diagnostic or serological tests on various promotional risks and regulatory obligations both before and after they secure Emergency Use Authorizations from FDA that allow the test to be distributed and used in the United States.
  • Prepared a Breakthrough Designation Request on behalf of a therapeutic developer client and helped another client secure Orphan Drug Designation for its innovative drug product.
  • Assisted multiple pharmacy clients in determining whether to register with FDA as an Outsourcing Facility and advised them regarding the compliance obligations associated with this form of compounding business, including with respect to applicable COVID-19 enforcement discretion policies.
  • Represent a national IVF clinic and management provider in drug delivery, pharmacy relationships, and delivery of care issues.
  • Counseled a publically traded medical device company on risk management advice and helped them manage multiple significant adverse events following suspension of trial by the FDA.
  • Provided strategic counsel to a start-up medical application company that has devised a method to detect mild cognitive impairment as a precursor to more significant cognitive diseases.
  • Advised a medical device company on possible FDA regulation of treatment of mobile wireless applications as medical devices.
  • Represented a foreign medical device company on FDA related issues regarding its U.S subsidiary.
  • Negotiated with FDA on behalf of a cosmetic client when a large shipment of imported products was detained by Customs and Border Protection due to non-compliant labeling and assisted company in developing plans for reconditioning the products.
  • Advise a food manufacturing company on multiple product line contract manufacturing arrangements and negotiated supply and quality agreements.
  • Guided a medical device manufacturer through multiple FDA inspections and developed effective and sustainable corrective actions to address deficiencies and avoid focused FDA enforcement.
  • Participated in marketing and labeling pre-launch team, working side by side with biological client team to craft marketing messages and product labeling for product launch.
  • Conducted a regulatory assessment and classification of software product used to support monitoring and management of patients with chronic obstructive pulmonary disorder.
  • Provided legal and regulatory advice to consumer app software collecting symptoms and providing guidance on possible next steps, including commercial agreements and new feature development.
  • Advised on legal and regulatory issues surrounding market launch of a software solution to gather patient data from peripheral devices and coordinate a communication and management platform with their physician, including licensing arrangements, clinical study agreements, and quality and supply agreements.
Case Study
Mintz helped a client launch a personal health assistant app for the US market. Mintz’s FDA Regulatory and Health Law practices advised the client on FDA and data privacy issues.
Case Study
Mintz is helping a client that manufactures medical technologies for facility and home-based care design and implement corrective actions in response to an FDA follow-up inspection. Although the client has two open FDA inspections, Mintz attorneys have helped the company avoid a warning letter.
Case Study
Mintz represents a company developing new drug therapies to treat neurodegenerative diseases and developmental disorders. Mintz advises the company on FDA issues, presentations to the company's board, and publication and presentation of the data.
Case Study
Mintz advised Glia, LLC on its successful bid to obtain orphan drug status from the FDA for its topical gel to treat ocular Graft-versus-Host Disease. The disease can affect stem cell or bone marrow transplant recipients and cause intense eye pain, ocular degeneration, and blindness.