Regulatory strategy

Chapter 1 examined the aims of regulation and identified the basic regulations currently in existence. This chapter looks at the broad strategies that are employed to achieve these goals, and the agencies that participate in leading industry towards these goals. 

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The basic regulatory strategy employed to safeguard public health relies on focussing attention on three main areas of activity product development product manufacture and market vigilance (see Figure 2.1). 

Regulatory Strategy for Medical Devices in the US 177 NON INVASIVE DEVICES... 

Implementation of process analytics in the pharmaceutical indusUy for continuous improvement purposes has received increased attention in recent years. Process analytics or PAT (see previous definition) has been identified as a key factor in continuous improvement initiatives and is seen as a central element of emerging regulatory strategies to enable these efforts as part of QbD. 

Before the end of phase 3, a decision is taken whether or not to file the compound, what the content and message of the dossier and what the regulatory strategy will be. Also the final decisions will be made on the production for marketing and on the anticipated pre-marketing requirements. This is the pre-filing decision point. 

Rosenfeld, M.G., Amara, S.G. and Evans, R.M. Alternative RNA processing events as a critical developmental regulatory strategy in nenroendocrine gene expression (1984) Biochem. Soc. Symp. 49, 27-44... 

Spence, A. Michael, and Martin L. Weitzman. 1978. Regulatory Strategies for Pollution Control. In Approaches to Controlling Air Pollution. Edited by Ann F. Friedlaender. Cambridge Massachusetts Institute of Technology Press. 

In practice, the strategy breaks with traditional industry-FDA modes of communication whenever PAT is concerned, it is anticipated that regulators will communicate directly with the pharmaceutical scientists and engineers involved with development and operation of the PAT system rather than indirectly via a department of regulatory affairs. The components of the agency s regulatory strategy include ... 

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