We have advised human tissue companies on how to transition a product from 361 HCT/P status to licensure as a biologic under section 351 of the Public Health Service Act.
We have assisted leading pharmaceutical companies in determining the appropriate classification of their tissue products in the EU.
We have advised gene therapy companies on genotyping programs.
We obtained Healthcare Common Procedure Coding System (HCPCS) codes for cellular therapies.
Assisted a client developing a gene therapy product for an orphan condition convince FDA to relinquish burdensome clinical trial endpoint requirements.
Counseled a gene therapy company and a company developing a drug to treat genetic obesity on genotyping programs and subject recruiting and patient identifying programs.
Counseled U.S. biotech companies seeking EU marketing authorization for advanced medicinal therapies, including issues involving clinical trials and patient identification.
