Who We Are

The New Jersey Life Sciences Vendors Alliance (NJLSVA) is a coalition of businesses, individuals and academia who provide goods and services to New Jersey’s life sciences companies.

The NJLSVA was founded to educate suppliers on trends in industry procurement and public policy that affects the life sciences industry.

Regenerative Medicine

FDA Announces Comprehensive Regenerative Medicine Policy Framework

Washington, DC, November 20, 2017 — The U.S. Food and Drug Administration (FDA) on November 16 announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies.

The framework – outlined in a suite of four guidance documents – builds upon the FDA’s existing risk-based regulatory approach to more clearly describe what products are regulated as drugs, devices, and/or biological products.

Further, two of the guidance documents propose an efficient, science-based process for helping to ensure the safety and effectiveness of these therapies, while supporting development in this area. Continue reading