NAVIGATING GOVERNMENT GUIDANCES FOR DEVELOPING COMBINATION PRODUCTS

摘要

Biomaterials used in healthcare products will require development and approval by the country's regulatory authority prior to release into the marketed sector. As noted in the Code of Federal Regulations (CFR), 21 CFR part 3.2(e) covers combination drugs. These regulations have been available for many years. It is only very recently that guidelines have been released by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) covering the regulation of combinations of drugs and devices.