ARTICLE | Politics & Policy

OMB reviews FDA's proposed rule for biological drug names

August 27, 2015 12:36 AM UTC

The White House Office of Management and Budget completed its review Tuesday of a proposed rule entitled "Designation of Official Names and Proper Names for Certain Biological Products." FDA had submitted the proposed rule to OMB on Friday. FDA declined to discuss with BioCentury the content of the rule or its relation to earlier biosimilar guidance. ...