The Regulatory Process

Continuous processes have lower labor costs but have higher failure risk. Batch processes can be started back up in a shorter period of time than can a complex continuous process. Batch processes are easier to take through the regulatory process than are continuous processes. Thus batch processes are often chosen for mammalian ceU culture systems, even though continuous processes can offer significant cost advantages. CeU culture costs constitute only a smaU (10—30%) fraction of the overaU cost of making a product. 

Table 3.1 The top 15 therapeutic categories on the basis of new products in the regulatory process in the United States in 2006.

Dick RB, Ahlers H. 1998. Chemicals in the workplace Incorporating human neurobehavioral testing into the regulatory process. Am J Ind Med 33 439-453. 

For a skeletal element to respond to its mechanical environment, the cells in the tissue must regulate their environment in response to the mechanical stimuli they receive. The regulatory process can be thought of as a feedback loop (Figure 7.5) in which the osteocyte senses the stimulus and... 

The regulatory process should be routinely and systematically monitored in order to identify problems in the process and determine whether the activities actually carried out are consistent with the intended course of action. Several approaches may be employed for assessing the performance of dmg regulatory authorities self-review, supervisory body review and peer review. These approaches can complement one another in appraising the performance of the DRA, as well as assisting it to identify areas for improvement. 

Registration requirements, SOPs and decision criteria are documented to ensure transparency of the regulatory process and to facilitate communication between the regulatory authority, the pharmaceutical industry and the public. 

The task of the DRA is to serve the public. Its operations must therefore be transparent to both clients (e.g. drug manufacturers) and consumers. Communication with clients should be a routine activity throughout the regulatory process. Information regarding its functions and the results of decisions should also be communicated regularly to the public. 

It helps us with public perception, it helps us in the political arena, and it helps us operate our plants better. And to their great credit, the NRC commissioners have shown the necessary leadership to reform the regulatory process. 

Discussion of the use of omics technology to detect hazards and inform the regulatory process... 

Lever (1987) presents an excellent overview of the regulatory process involved in FDA oversight of drug development, and gives the historical perspective for the evolution of the conservative process that is designed to ensure that any new pharmaceutical is both safe and efficacious. 

It is important for development scientists to familiarize themselves with the regulatory process, which defines the development stages of a biopharmaceutical. Along this path there are several checkpoints that must be passed before reaching the next plateau. These checkpoints (or phases) affect all groups within... 

In Chapter 8 we examine more closely the regulatory processes for testing, trialing, and approving a drug for marketing. 

The regulatory process is the filing of an IND for clinical trials. At the conclusion of clinical trials, the Sponsor files a Biological License Application (BLA) for marketing approval. The CBER evaluates a biologic in terms of risk versus benefits before approving it for marketing. 

The Noerr-Pennington doctrine often protects participation in the regulatory process from antitmst scmtiny. As discussed in Chapter 4, in its simplest terms, the Noerr-Pennington doctrine shields private parties from antitrust liability when they engage in concerted but genuine efforts to influence governmental action, even though the conduct is undertaken with an... 

It is anticipated that elucidation of the fine tuning of the regulatory processes in endothelial ceUs under pro-inflammatory conditions, will lead to the identification of additional novel pharmacological targets in the near future. 

The regulatory process which allows the product to be marketed. 

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