ABSTRACT
Regulations that describe reporting requirements for postapproval changes have a significant economic impact on the pharmaceutical industry. These regulations can be found at Title 21 of the Code of Federal Regulations (21 CFR), Sections 314.70 for drugs and 601.12 for biological product (1). The postapproval reporting regulation for biological products, entitled "changes to be reported," prior to revision in 1997, constituted one of the most burdensome regulatory obligations, because it required reporting of all "important" changes to manufacturing methods and labeling in advance of implementation. Enforcement of the original regulation at 21 CFR § 601.12 provided an example of how regulations can become burdensome when strict and limiting interpretations of specific language are applied. In this instance the ambiguous word important was the term used to define changes that required preapproval.
