Regulatory outline

The Corrective Measures Study (CMS) elements as outlined in the EPA document entitled RCRA Corrective Action Plan - Interim Final (U.S.EPA, 1988) provides guidance to the regulatory community on the steps practiced by the engineering community in the conduct of a feasibility study. These steps include ... 

In addition to the rules, regulations and procedures provided above for emergency planning and response, each state (in tlie United States) is actually involved in other environmental management activities. Recently, Matystik et al lia C prepared a suiiuiiary outline for interested users on tliese otlier state regulatory initiatives. The outline is a baker s dozen of information wliicli include the following for each state ... 

The previous chapter outlined how device classification and the use of standards provide the basis for effective regulation of medical devices, with particular focus on the application of design control standards to the development of devices. In this chapter we look at the process for evaluation and authorisation of devices, and see how the regulatory requirements vary depending on the perceived risk of the device as indicated by its classification. It will be noted that there is considerable variation between the approaches adopted in Europe and the US and that, compared to dmgs, practical harmonisation of requirements still remains to be adopted. 

Surveillance requests are usually targeted at particular concerns, vhich the FDA vill specify as part of the scope of the surveillance order. The manufacturer must submit a plan to the FDA outlining ho v the surveillance vill be conducted. Once approved, the surveillance plan must be put into effect, usually for not more than 3 years, and any reports agreed as part of the plan must be submitted to the FDA. Surveillance plans are quite similar in concept to the safety studies that may be agreed vith regulatory authorities for drugs. 

The smooth muscle cell does not respond in an all-or-none manner, but instead its contractile state is a variable compromise between diverse regulatory influences. While a vertebrate skeletal muscle fiber is at complete rest unless activated by a motor nerve, regulation of the contractile activity of a smooth muscle cell is more complex. First, the smooth muscle cell typically receives input from many different kinds of nerve fibers. The various cell membrane receptors in turn activate different intracellular signal-transduction pathways which may affect (a) membrane channels, and hence, electrical activity (b) calcium storage or release or (c) the proteins of the contractile machinery. While each have their own biochemically specific ways, the actual mechanisms are for the most part known only in outline. 

Each of these key dmg regulatory functions is designed to accomplish the four interrelated objectives outlined above. Some regulatory functions relate directly to dmg regulation objectives, while others play a complementary role in assuring successful implementation of another function. So in evaluating the effectiveness of dmg regulatory policy, two concepts must be clear, namely ... 

Once the determinative or confirmatory method has been developed to take full advantage of the chemical properties of the analyte molecule, a study is necessary to prove that the method is valid. Criteria for method validation are outlined in guidelines from the US FDA, US EPA, and EU. A summary of the differences in regulatory requirements for method validation is provided in Table 3. The parameters addressed by all of the regulatory guidelines include accuracy, precision, sensitivity, specificity, and practicability. 

The preparation of a new drug substance or dosage form for evaluation in clinical trials must meet the same regulatory requirements and controls as a marketed product. The cGMP requirements for clinical trial products are outlined by FDA and are discussed in Chapter 20. 

This chapter presents a regulatory overview of on-site remediation, remedial investigations (RI), feasibility studies (FS), remedial technologies, and a simulated case study. The discussion of remedial investigations and feasibility studies also includes the development and selection of remedial technologies. The case study outlines a remedial investigation and feasibility study, as well as the selection of remedial technologies. 

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