RAPS: FDA Amends Regulations on General Biologic Standards for First Time Since 1977

The revisions to US Food and Drug Administration’s (FDA) regulations, announced Tuesday, are designed to remove unnecessary or outdated biologics requirements and allow industry to employ new manufacturing technology and testing capabilities. Issued directly as a final rule – because FDA says it believes the updates include “only noncontroversial amendments” and FDA anticipates no major objections from industry – the new regulations are part of FDA’s continuing effort to reduce the burden of unnecessary regulations. The regulations were last altered in 1977.