Overview
Ropes & Gray routinely advises clients on regulatory matters affecting manufacturers of products regulated by FDA’s Center for Biologics Evaluation and Research (CBER). These matters encompass not only general FDA regulatory issues – such as Biologics License Application (BLA) approvals and biological device clearances, REMS implementation, pharmacovigilance, advertising and promotion, and GMP – but also issues specific to vaccines, blood products, HCT/Ps, gene therapy products, and stem cells.
Our lawyers were also significantly involved in the legislative process that ultimately resulted in the passage of the Biologics Price Competition and Innovation Act of 2009, and thus are very familiar with the new regulatory regime governing biosimilars.
Experience
Examples of our biologics representations include:
- Assisted clients developing stem cell treatments on navigating regulations concerning HCT/Ps and GTPs.
- Advised a vaccine manufacturer on addressing issues identified by FDA in a complete response letter relating to the manufacturer’s BLA.
- Drafted a trade complaint for a client concerning its competitor’s product based on failure of the competitive product to satisfy HCT/P requirements.
- Conducted a comprehensive review of blood screening, collection, and processing procedures on behalf of a national blood banking system.
- Worked extensively with major biotechnology companies on multi-year legislative efforts associated with the development and passage of biosimilars legislation.
