BioPhia Consultant Ed Moore presents a training video as part of the Great Lakes Medical Jumpstart I-CORPS program discussing the regulatory paths associated with therapeutic biologic products.
The FDA describes biological products as those that are generally derived from living material (human, animal, or microorganism), are complex in structure (unlike drugs which have well-defined chemical structures), and thus are usually not fully characterized. Both the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products. Included in this regulatory overview are the major approval considerations and requirements for a Biologics License Application (BLA) submission.
Comments