Approvals process, regulatory

Sucrose polyesters, which are made by esterilying sucrose with long-chain fatty acids, have the physical properties of fat, but are resistant to digestive enzymes (40). Olestra, a sucrose polyester developed by Procter Gamble, was submitted for regulatory approval in May 1987. In order to faciUtate the approval process, Procter Gamble has since narrowed the scope of its food additive petition to include olestra s use only in savory and extmded snacks. 

The issue that must be managed is the appropriate threshold to communicate the change and initiate appropriate approval processes. Tolls subject to regulatory requirements may use the regulatory guidance as the threshold for management of change processes other tolls must establish the threshold appropriate to process risks, quality systems, and business concerns. 

The NADA method approval process consists of three phases (1) method development by the sponsor and generation of information to establish that the method satisfies acceptability criteria (2) FDA review of the sponsor s data to determine suitability of the method and (3) the method trial , an inter-laboratory study, which determine whether the method meets performance criteria when used in multiple laboratories. The inter-laboratory method trial procedure provides an indication of a method s ability to be used as a practicable and reliable regulatory tool. Sponsors are urged to develop methods that are mgged and exceed rather than meet the minimal standards of acceptability. Those methods that appear marginally acceptable after review often do not pass the inter-laboratory method trial. 

New Drug Approval Process Clinical and Regulatory Management,... 

A report by the National Renewable Energy Laboratory, studied 65 distributed energy projects and found that various technical, business practice, and regulatory barriers can block distributed generation projects from being developed. These barriers include lengthy approval processes, project-specific equipment requirements and high standard fees. 

Before deseribing the seope of the study, it is important to understand the historical context in whieh Hateh-Waxman arose. Moreover, the generie approval process Hatch-Waxman implemented demands an understanding of the interaction of the patent system and the regulatory structure governing the approval of brand-name drugs. 

There are two distinct phases in the process that eventually results in the availability of a new domestic product, and the proper measure of cost from a societal perspective depends on the phase in which one is in. To be successfully offered, a product must first go through several phases of research, development, and clinical testing culminating in regulatory approval. Once regulatory approval is achieved, firms then incur additional costs to market, produce, distribute, and transport the product. 

Because of the elevated iron concentration and low pH created by the ISOTEC process, regulatory approval may be required for some sites. The process can also create a temperature increase in the subsurface. According to the vendor, this increase can be as high as 10°C and lasts less than 24 hr. 

A regulatory framework and approval process was set up to avoid inadvertent release of material, to ensure environmental safety, and to protect the integrity of the plant product intended for food or animal feed. Much overlap exists between the agencies responsible for addressing these issues. 

The evaluation as a food additive or GRAS substance may provide relevant safety information to support the use of a proposed new excipient in a drug product. The evaluation of a new excipient that is to be used orally as a food additive and that is evaluated independent of the drug product approval process may serve as a review of the safety of the excipient by a recognized regulatory authority. 

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