OFW Law’s attorneys have extensive knowledge of FDA's regulatory program for human cell and tissue products (HCT/P). We advise clients on the establishment registration, product listing, donor screening and testing, and current good tissue practices, labeling and reporting requirements for HCT/Ps. In addition, we advise on inspection matters and enforcement actions involving HCT/Ps. We also act as an important resource for clients engaged in business matters requiring expertise in FDA HCT/P regulation. For example, we assist with due diligence evaluations of FDA HCT/P compliance and provide advice on contractual language for mergers and acquisitions involving HCT/P firms and/or products. We also assist in drafting FDA-related disclosures and statements for securities filings for HCT/P firms, and can provide litigation support involving HCT/P issues.
We have extensive experience in filing data related to cellular and stem cell therapy. Additionally, we have assisted in the initiation of some of the first clinical trials of human stem cells.
For more information about our services, contact OFW Law’s Washington D.C. offices by telephone at (202) 789-1212 or complete our online contact form. We look forward to working with you.