Overview
Ropes & Gray’s life sciences regulatory & compliance team routinely advises clients on the full spectrum of regulatory matters affecting manufacturers of products regulated by the FDA’s Center for Biologics Evaluation and Research (CBER). These matters encompass general FDA regulatory issues—including Biologics License Application (BLA) strategy and approvals, biological device clearances and approvals, design and implementation of risk evaluation and mitigation strategies (REMS), pharmacovigilance and post-market safety reporting, advertising and promotion compliance, and current Good Manufacturing Practice (cGMP) requirements—as well as specialized issues involving vaccines, blood products, human cells, tissues, and cellular and tissue-based products (HCT/Ps), gene therapy products and other cell-based therapies, and regenerative medicine advanced therapies (RMATs).
Experience
Representative matters include:
- Advising stem cell treatment developers on navigating regulations concerning Good Tissue Practice (GTP) requirements and HCT/Ps.
- Counseling companies developing gene and cell-based therapies on safety profiles and risk mitigation strategies, Long-Term Follow-Up (LTFU) study requirements, informed consent protocols, Investigational New Drug (IND) submissions, and FDA interactions throughout the clinical development process.
- Counseling healthcare institutions on FDA regulatory issues that may impact their use of HCT/Ps.
- Advising vaccine manufacturers on preparing BLAs, addressing issues identified by the FDA in Complete Response Letters (CRLs), developing strategies for BLA resubmissions, and navigating expedited review and approval pathways such as Priority Review.
- Conducting comprehensive reviews of blood screening, collection, and processing procedures on behalf of national blood banking systems.
- Working extensively with major biotechnology companies on multi-year legislative efforts associated with the development and passage of biosimilars legislation.
- Counseling biosimilar developers on FDA approval strategies, clinical study design, and interchangeability determinations.
- Representing clients in FDA enforcement matters involving biologics, including responding to FDA inspection reports (483s) and Warning Letters, conducting internal investigations, and negotiating consent decrees related to cGMP compliance.
- Advising on regulatory strategies for combination products involving biologics and devices, including pre-submission meetings with the FDA and coordination of BLA and device submission components.
