LIFE SCIENCES INDUSTRY / LIFE SCIENCES FDA RESEARCH, ENFORCEMENT & LITIGATION
With enhanced compliance requirements and a constantly evolving set of regulations and laws presiding over the life sciences industry, our team of attorneys advise clients on the full spectrum of business and legal issues relating to the marketing and promotion, distribution and commercialization of FDA regulated products.
Dinsmore’s experienced FDA team is critical to our regulatory counseling portfolio. As a national law firm with Mid-West pricing, our attorneys are able to work closely with clients from individual entrepreneurs to Global 100 companies to develop customized legal services and pricing models tailored to their business plan. Our FDA practice includes attorneys with professional experience as medical researchers, scientists, bioethicists, and a former senior FDA policy adviser, each contributing their technical and practical know-how to advise clients across the life sciences industry. Because our FDA regulatory consultants are licensed practicing health care attorneys, they never lose sight of the bigger regulatory picture. They are highly qualified to identify related legal risks and business opportunities that occur when other federal and state laws converge with the Federal Food, Drug, and Cosmetic Act (FD&C Act) throughout the life-cycle of our clients’ products.
At Dinsmore, we take a hands-on role to support our clients’ product development and scientific teams so they can accomplish more. Our FDA attorneys skillfully navigate through the FD&C Act to assist our clients develop the most favorable and legally savvy regulatory strategy to commercialize their products. Our FDA team can act as an embedded regulatory team member for clients or as outside counsel.
- Strategize to determine the classification and regulatory pathway for U.S. and other international markets.
- Expedite Emergency Use Authorization (EUA) submissions.
- Work with clients to develop, prepare, and submit Pre-Submission meeting requests, 510(k)s, PMAs, IDEs, de novo reclassification requests and 513(g) requests for classification, OTC monograph order request (OMOR), INDs, ANDAs, NDAs, Non-filling justifications (Letters to File), Technical Files and Clinical Evaluation Reports.
- Provide proactive risk mitigation and troubleshoot client-prepared regulatory documentation.
- Negotiate in meetings and written interactions with federal and state regulators.
- Draft agreements, consent forms, and file documents for U.S. and outside U.S. clinical studies intended to support FDA regulatory submissions.
- Deliver training and risk evaluations for Expanded Access and unapproved use of approved products.
- Assist clients in developing work plans for the use of Real World Evidence and patient preferences in regulatory strategies.
- Advise clients on reporting obligations, adverse events, product recalls, and other disclosures related to product safety.
- Review labeling, advertising, and promotional activities.
- Guide clients through administrative requirements (e.g., registration, product listing, CLIA certification, MDR reports).
- Draft contracts, technology transfer licenses, Non-Disclosure Agreements, and Business Associate Agreements.
- Counsel clients on CMS and insurance reimbursement issues, Anti-kickback, Sunshine and transparency laws, HIPAA, and privacy and confidentially laws.
- Defend against trade secret disclosures and FOIA requests.
- Advocate for clients in mediation, dispute resolution, and appeals of unfavorable regulatory decisions and Consent Decree negotiations.
- Represent clients in various types of FDA enforcement actions, including FDA inspections, responses to FDA 483 Inspectional Observations, and untitled and warning letters.
- Conduct bioethical review and Good Clinical Practice education and training for IRB and clinical investigator staff.
- Provide continual regulatory updates and legal analysis of FDA legislation, regulation, and enforcement trends.
- Draft comments and position statements for proposed FDA rulemaking and guidance.
- Identify and assess novel regulatory considerations in digital health technology, including mobile health devices, software as a medical device (SaMD), Artificial Intelligence, and Machine Learning technologies.