Drug companies will have more clarity over how the FDA regulates their products following an agency rule revising the definition of certain complex and expensive drugs.
The Food and Drug Administration, in a rule set to publish Friday in the Federal Register, squares its regulatory definition for those drugs, called biologics, with the definition Congress agreed to in a spending deal in December 2019.
The rule is aimed at setting the framework for a new requirement, set to take effect March 23, under which companies seeking to bring certain drug products to market will have to submit an application for ...
Learn more about Bloomberg Law or Log In to keep reading:
See Breaking News in Context
Bloomberg Law provides trusted coverage of current events enhanced with legal analysis.
Already a subscriber?
Log in to keep reading or access research tools and resources.