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
Insights
- Podcast: Non-binding Guidance: Continued Global Pressure on Drug Pricing & Reimbursement and the Next Frontiers for Effective Market Access
(October 13, 2022) - Latest Legislative Developments in the UK on Retained EU law The Retained EU Law (Revocation and Reform) Bill Implications for Healthcare and Life Sciences Industry
(October 6, 2022) - UK NICE Updates its Evidence Standards Framework for Data-Driven Digital Health Technologies
(October 5, 2022) - Congress Enacts Clean Reauthorization of FDA User Fees, Leaving Uncertain Future for Important Policy Reforms
(September 30, 2022) - Harmonizing the Common Rule and U.S. Food and Drug Administration Human Subjects Research Regulations
(September 30, 2022) - Latest Post-Brexit UK Regulatory Development on Medical Devices and in Vitro Diagnostic Medical Devices: UK Government Response to the Future UK Regulatory Framework
(July 29, 2022)