Generic drugs, regulation

A drug whose labeling or promotional materials makes reference to a specific device or generic class of devices ordinarily remains a drug regulated by CDER. It may, however, also be subject to the combination products regulation. 

This chapter reviews FDA regulations concerning the use of citizen petitions. It also examines the citizen petitions that brand-name companies have filed about drug products in this study, and discusses their effect on the development of generic drug competition for these drug products. 

The FDA has available to it a wide variety of formal and informal enforcement authorities under the FD C Act. They apply equally to all products regulated by FDA. For generic drugs, FDA also can rely upon the provisions of the... 

Generic Drug Enforcement Act of 1992. The following sections summarise some of the more important enforcement provisions used by FDA to regulate all pharmaceutical products. 

Marketing of less-costly generic drugs is expedited with congressional passage of the Dmg Price Competition and Patent Term Restoration Act. Under the new regulations, the FDA could approve applications for... 

Therefore, it would appear that the orphan drug regulations provide some flexibility to the sponsor (generic) in establishing product sameness but also reaffirm the important role of clinical data in supporting product safety and efficacy. 

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