License accelerated licensing

WASH-1400 did not analyze seismic events, but if they had, the risk they assessed would have been larger. Earthquake analysis was part of the FSAR for licensing a plant and had been practiced for some time before the RSS. This analysis included earthquake frequencies from historical records, ground-coupling models to estimate the intensity and frequency spectrum of the acceleration, and spring-mass models to estimate the forces on plant components under the... 

At this point, discussion shifted to additional tests the advisory committee members expected in return for expanding Proleukin s approved uses. Committee members were deeply divided between suggesting accelerated or traditional approval. As one member noted, a full product license would give FDA officials little authority to demand additional clinical research. Accelerated approval, on the other hand, could be used to force the company to submit ongoing reports from clinics that observed and cared for patients after treatment. 

Code Simulation implementation GPU acceleration Multiple GPU support GPU type Licensing model... 

The amount of scientific information contained in a licensing application may be vast (often exceeding 1000 pages). The pharmaceutical company presents evidence to show that every aspect of production of the medicinal product has been controlled and validated and is of an acceptable quality. The application starts with a description of the discovery chemistry for the new drug. This may be a chemical synthesis or an extraction of an active natural product from a plant or microorganism. Spectroscopic (e.g. NMR, MS, IR) and chromatographic (e.g. HPLC, GC) data are presented to show that the correct compound has been synthesised, and that by-products are identified and their levels controlled. The new chemical entity is then subjected to stability testing under accelerated conditions of heat, humidity, etc. to calculate shelf-life and rates of decomposition. Each decomposition product is identified and any potential toxicity is controlled. 

The value of vaccines, even in the limited uses described above, justifies an accelerated research effort to improve the licensed vaccines, such as the anthrax, plague, and smallpox vaccines, and to complete the development process and seek licensure for those vaccines still in IND status. 

UOP developed two varieties of zeolite catalyst designated as QZ-2000 and QZ-2001 (47,48). Its research indicated that the catalysts have Bronsted acidity values. As a result, oligomerization of propylene is essentially eliminated. Accelerated stability tests indicated that the percentage of the bed of catalyst employed for desired reactions increases with time of operation. QZ-2001 demonstrates improved stability and operation at benzene/propylene ratios of 2.0 in its liquid-phase process. Unreacted benzene and polyisopropylbenzenes are recovered and recycled so that cumene jdelds of about 99% are obtained. Four catalyst beds in series are employed. The catalysts need to be reactivated after about 2-5 years. UOP have licensed several units. 

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