Idea Exchange
FDA Regulatory Compliance & Litigation
Insights & practical guidance for clients navigating FDA regulation
We are committed to helping you achieve your business goals, stay on budget, and maximize return on investment by
- Assisting you to develop your target product profile, conduct nonclinical research and clinical trials, and get to and stay on market
- Drafting FDA regulatory submissions and preparing responses to agency enforcement actions
- Understanding FDA, CMS, DEA, FTC, and USDA laws, regulations, guidance documents, and policies
- Representing your interests before, during, and after FDA interactions
- Anticipating and avoiding regulatory and litigation risks
Interdisciplinary team and collaborative approach
Our team consists of experienced attorneys who collaborate with other professionals when needed to advise or solve our clients’ most complex and sophisticated problems
- Lawyers who have worked in the public and private sectors and developed a keen understanding of the real issues that our clients face when navigating the FDA regulatory framework
- Patent, intellectual property, and products liability litigators to anticipate and avoid litigation risks
- Public policy advisors and strategists with diverse federal and state government experience
- Corporate attorneys to assist with life sciences transactions, collaborations, and government securities filings
- Regulatory and quality consultants, including former FDA inspectors and regulators
Our diverse clients share the common goals of successfully navigating FDA requirements while meeting their business objectives
- Pharmaceutical companies (human and animal health)
- Medical device companies, including In Vitro diagnostic manufacturers
- Biotech and digital health companies
- Nutraceutical/dietary supplement companies
- Cosmetics manufacturers
- Radiation-emitting electronic product companies
- Clinical laboratories
- Clinical research facilities, including private practice groups
- Analytical laboratories
- Food and food packaging companies
- Public and private healthcare and service providers
- Hospitals and healthcare systems
The Nelson Mullins FDA Compliance & Litigation Team has the deep experience to address the challenges faced by and opportunities presented to FDA-regulated industries
Our team has experience advising general counsels, industry associations, executives, quality and regulatory functions, private equity firms, clinical research professionals, laboratory directors, physicians, and other healthcare providers. From preparing our clients for meetings with the FDA to identifying creative regulatory solutions, our team is committed to standing with our clients at every step of the regulatory process.
FEATURED ATTORNEY
Experience
The following is a selected sampling of matters and is provided for informational purposes only. Past success does not indicate the likelihood of success in any future matter.
- Represented clients in preparing, reviewing, and filing FDA medical device and pharmaceutical submissions, including 513(g) requests, pre-submission meeting requests, IDEs, 510(k) premarket notifications, PMAs, INDs, BLAs, and NDAs
- Served as regulatory counsel for industry associations and life sciences manufacturers at FDA and CMS meetings concerning proposed rulemakings, draft guidance documents, and agency enforcement
- Supported medical device manufacturers and clinical laboratories in drafting numerous Emergency Use Authorization (EUA) submissions during the COVID-19 public health emergency
- Guided medical device and pharmaceutical companies through FDA inspections and assisted in preparing responses to FDA Form 483 Inspectional Observations and Warning Letters
- Supported life sciences companies through voluntary product recalls and market withdrawals
- Counseled clients in appeals, dispute resolution, and consent decrees with FDA
- Successfully petitioned FDA for removal of cosmetics and medical devices from agency import alerts
- Developed clinical trial playbooks for pharmaceutical, medical device, and nutraceutical/dietary supplement manufacturers as well as healthcare facilities
- Assisted life sciences companies with comprehensive product labeling, advertising, and promotional reviews
- Conducted large-scale, internal compliance assessments of global pharmaceutical companies, medical device manufacturers, and hospital systems
- Led FDA regulatory due diligence in conjunction with life sciences transactions, collaborations, and government securities filings
- Prepared request for a hearing in response to FDA’s Notice of Opportunity for Hearing
- Advised clients on FDA’s regulation of radiation-emitting electronic products
- Counseled clients on FTC regulatory compliance and enforcement
- Assisted clinical laboratories with federal and state CLIA compliance, inspections, and enforcement
- Drafted state legislation signed into law regarding the regulation of clinical laboratories
- Advised laboratories on compliance with SAMHSA drug testing mandatory guidelines and forensic toxicology accreditation
- Counseled clients on USDA regulation of veterinary biologics
Interdisciplinary team and collaborative approach
Our team consists of experienced attorneys who collaborate with other professionals when needed to advise or solve our clients’ most complex and sophisticated problems
- Lawyers who have worked in the public and private sectors and developed a keen understanding of the real issues that our clients face when navigating the FDA regulatory framework
- Patent, intellectual property, and products liability litigators to anticipate and avoid litigation risks
- Public policy advisors and strategists with diverse federal and state government experience
- Corporate attorneys to assist with life sciences transactions, collaborations, and government securities filings
- Regulatory and quality consultants, including former FDA inspectors and regulators
Our diverse clients share the common goals of successfully navigating FDA requirements while meeting their business objectives
- Pharmaceutical companies (human and animal health)
- Medical device companies, including In Vitro diagnostic manufacturers
- Biotech and digital health companies
- Nutraceutical/dietary supplement companies
- Cosmetics manufacturers
- Radiation-emitting electronic product companies
- Clinical laboratories
- Clinical research facilities, including private practice groups
- Analytical laboratories
- Food and food packaging companies
- Public and private healthcare and service providers
- Hospitals and healthcare systems
The Nelson Mullins FDA Compliance & Litigation Team has the deep experience to address the challenges faced by and opportunities presented to FDA-regulated industries
Our team has experience advising general counsels, industry associations, executives, quality and regulatory functions, private equity firms, clinical research professionals, laboratory directors, physicians, and other healthcare providers. From preparing our clients for meetings with the FDA to identifying creative regulatory solutions, our team is committed to standing with our clients at every step of the regulatory process.
The following is a selected sampling of matters and is provided for informational purposes only. Past success does not indicate the likelihood of success in any future matter.
- Represented clients in preparing, reviewing, and filing FDA medical device and pharmaceutical submissions, including 513(g) requests, pre-submission meeting requests, IDEs, 510(k) premarket notifications, PMAs, INDs, BLAs, and NDAs
- Served as regulatory counsel for industry associations and life sciences manufacturers at FDA and CMS meetings concerning proposed rulemakings, draft guidance documents, and agency enforcement
- Supported medical device manufacturers and clinical laboratories in drafting numerous Emergency Use Authorization (EUA) submissions during the COVID-19 public health emergency
- Guided medical device and pharmaceutical companies through FDA inspections and assisted in preparing responses to FDA Form 483 Inspectional Observations and Warning Letters
- Supported life sciences companies through voluntary product recalls and market withdrawals
- Counseled clients in appeals, dispute resolution, and consent decrees with FDA
- Successfully petitioned FDA for removal of cosmetics and medical devices from agency import alerts
- Developed clinical trial playbooks for pharmaceutical, medical device, and nutraceutical/dietary supplement manufacturers as well as healthcare facilities
- Assisted life sciences companies with comprehensive product labeling, advertising, and promotional reviews
- Conducted large-scale, internal compliance assessments of global pharmaceutical companies, medical device manufacturers, and hospital systems
- Led FDA regulatory due diligence in conjunction with life sciences transactions, collaborations, and government securities filings
- Prepared request for a hearing in response to FDA’s Notice of Opportunity for Hearing
- Advised clients on FDA’s regulation of radiation-emitting electronic products
- Counseled clients on FTC regulatory compliance and enforcement
- Assisted clinical laboratories with federal and state CLIA compliance, inspections, and enforcement
- Drafted state legislation signed into law regarding the regulation of clinical laboratories
- Advised laboratories on compliance with SAMHSA drug testing mandatory guidelines and forensic toxicology accreditation
- Counseled clients on USDA regulation of veterinary biologics
- Track record of resolving FDA compliance issues to reduce regulatory exposure
- Creative and practical approaches to navigating the FDA regulatory scheme
- Significant experience interacting with FDA officials and other federal and state agencies, including CMS, DEA, FTC, SAMHSA, and USDA
- Deep pharmaceutical and medical device litigation experience and insight to help clients develop proactive regulatory and risk avoidance plans
