background good drug regulation requires an effective system for monitoring and inspection of manufacturing and sales units. in india, despite widespread agreement on this principle, ongoing shortages of drug inspectors have been identified by national committees since 1975. the growth of india’s pharmaceutical industry and its large export market makes the problem more acute.   methods the foc...

The marine environment is a rich source of both biological and chemical diversity. This diversity has been the source of unique chemical compounds with the potential for industrial development as pharmaceuticals, cosmetics, nutritional supplements, molecular probes, fine chemicals and agrochemicals. In recent years, a significant number of novel metabolites with potent pharmacological propertie...

One of the key underlying issues facing the development of all drugs, and particularly orphan drugs, is what kind of evidence the Food and Drug Administration (FDA) requires for approval. The Federal Food, Drug, and Cosmetic [FD&C] Act provides that for FDA to grant approval for a new drug, there must be “substantial evidence” of effectiveness derived from “adequate and well-controlled investig...