ABSTRACT
The U.S. Food and Drug Administration (FDA) has as its legislative mandate the regulation of all drugs manufactured or marketed in the United States. When the agency uses the term ‘‘drug,’’ it includes within that definition biologics. The regulation of drugs is basically separated into two categories: those for which preapproval is not required, which includes those that are considered generally recognized as safe and effective (GRASE), and those that require preapproval in the form of the submission of a New Drug Application (NDA) or an
Abbreviated New Drug Application (ANDA) (1). For those that fall into the category of being under review or GRASE, including all those subject to the over-the-counter (OTC) Monograph system, there is no preapproval requirement and, therefore, no submission of information required for the product to enter the marketplace. For those drugs that require the submission of a drug application, it is highly likely that the application will be dependent on the submission of clinical data or bioequivalence studies to demonstrate that the product is safe and effective. Just as the submission of the application is subject to various statutory and regulatory requirements, the clinical or bioequivalence testing necessary for obtaining approval of an NDA or ANDA is covered by a number of statutory and regulatory provisions.
