Backgrounders

BIO Principles on Vaccine Financing Policy
The European Medicines Agency (EMEA), the European equivalent to the Food and Drug Administration (FDA), has implemented an approval scheme that specifically distinguishes between biosimilars (follow-on biologics) and generic drugs. The EMEA recognized that "due to the complexity of biological/biotechnology-derived products the generic approach is scientifically not appropriate for these products." /1
Research institutions, companies and producer groups engaged in the growing field of animal biotechnology place animal well-being as a top priority. The humane care and use of animals in genomics, cloning and transgenics is guided by rigorous regulatory review and, in some instances, third party review. Regulatory Overview
At BIO’s recent Focus on Compliance workshop, participants learned about the responsible use of plant biotechnology during R&D. Attendees from academia, government and corporations walked away from the event with a better understanding of how to comply with federal requirements during field trials of genetically engineered crops such as corn, cotton and soybeans.
Myths abound regarding data exclusivity and the ability of an innovator to extend the period of data exclusivity as provided in the health care reform bill passed by the U.S. House of Representatives and legislation currently under consideration in the Senate. It’s time to set the record straight.