FDLI Virtual Conference - Regenerative Medicine: Regulatory, Enforcement, and Legal Challenges for Cell and Gene Therapies

Barbara Binzak Blumenfeld, Shareholder in the FDA & Biotechnology practice group, moderated a gene therapy panel on April 2 as part of the Food and Drug Law Institute’s day-long “virtual” conference, “Regenerative Medicine:  Regulatory, Enforcement, and Legal Challenges for Cell and Gene Therapies.”  Barbara’s panel focused on recent FDA guidance that applies to various aspects of gene therapy development, such as manufacturing, long-term follow-up of patients after receiving gene therapy, and special considerations for rare diseases.

FDLI is a nonprofit membership organization founded in 1949 that offers a venue for food and drug law stakeholders to discuss and learn about legal and regulatory issues involving all of FDA’s regulated products.  Barbara is currently a member of FDLI’s Austern Writing Awards Committee.