Regulations and drug development

In the previous chapter (Chapter 21), we described how the pharma industry and the FDA work together today, respectively, to develop and approve new drugs, and to ensure their safe use in the marketplace. In this chapter, we consider the future course and prospects for regulation and drug development. 

Warden W, Lasagna L, Regulation and Drug Development, American Enterprise Institute for Public Policy Research, Washington, DC, 1975. 

W. Wardell and L. Lasagna, Regulation and Drug Development", American Enterprise Institute, 1975. 

Anon. (1998a). Annual Report of the Pharmaceutical Research and Manufacturer s Association. (Priority 2 Improved FDA Regulation of Drug Development). 

Genetics education Drug development and regulation Human genetic variation Genomics and drug development SNPsa... 

To improve systems of cind revise regulations for drug development, reviewing system and post-marketing surveillance in order to secure drug safety. 

Knowledge and skills are required for the specific regulations governing drug development in the USA. These include Title 21, Code of Federal Regulations Parts 50,56,312 and 314. 

The exact role of individual histone acetylations will have to be determined in the context of other modifications and the number of lysine residues effected. However, the general importance of histone acetylation as a regulator for chromatin activity is undisputed. This leads to the intriguing possibility to develop drugs that target histone acetylation for therapeutic purposes. The primary targets for drug development are the histone acetyl transferases (HATs) and the histone deacetylases (HDACs) which introduce and remove histone acetylations [2, 3]. 

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