Regulatory hurdles

It is more expensive to build nuclear plants which cost 2,000 per kilowatt-hour of output, compared with 1,500 for coal plants and 800 for gas plants, according to the International Energy Agency. It takes years to go through the regulatory hurdles for a new nuclear plant, build it and obtain a license to operate. Any new plants conceived today may be 10... 

The challenges facing the pharmaceutical industry in 2012 are significant. There is a perceived decline in the productivity of R and D, significantly higher regulatory hurdles to market entry (particularly in the key US market),... 

Subutex and Suboxone are unique not so much for their chemical makeup or mode of operation, but for the regulatory hurdles they overcame. Unlike other pharmacotherapies for heroin addiction (e.g, methadone, naltrexone, ORLAAM °), which can only be dispensed by specialized Opioid Treatment Clinics, specially-trained doctors are permitted to prescribe Subutex and Suboxone drugs in a standard office setting under the Drug Addiction Treatment Act (DATA) of 2000."... 

The main attraction of stromal culture of hematopoietic cells is their superior ability for stem cell expansion especially in direct co-culture. However, despite this, a clinical use has not been realized until now. The major drawback is the origin of the stromal support. While autologous stroma would be feasible, in many cases this is not reaHzable. Furthermore, the use of cell Hnes (although irradiated to prevent further proliferation) is problematic as all stromal cells have to be removed completely prior to transplantation, a demand which is difficult to fulfill. In the case of murine cell Hnes a transfer of residue cells into a patient would be a xenotransplantation, which is faced with extensive regulatory hurdles. 

Drug adverse events will always remain part of modern medicine and the potential for another thalidomide disaster cannot be totally dismissed. The prevention of a future disaster lies, not in simply increasing the number of regulatory hurdles but in the ability to communicate and control unexpected events and where necessary make rapid withdrawal from the market. 

DeMerlis CC, Goldring JM. Marketing new excipients, clearing regulatory hurdles. Phar-maceut Technol 2003 102-108. 

Moore, S.D. Norvabs Jumps Last Regulatory Hurdle and Major Drug-Industry Force Is Bom, Wall Street Journal, B4 (Dec. 18, 1996). 

Increased animal use with little predictive value for human risk (based on one or more of the above considerations) raising regulatory hurdles for similar products in the future... 

Donnelly J, Berry K, Ulmer JB. Technical and regulatory hurdles for DNA vaccines. Int J Parasitol 2003 33 457-67. 

The reasons for the slow introduction of new pigments may be that the regulatory hurdles for newly introduced chemicals are high, and also that customers are making more demands on the performance of new materials and the Three Essential E s Effectiveness, Economy and Ecology. 

The risks of moving into biotechnology are much smaller in other chemical businesses than they are in the agrochemicals sector. Consumer acceptance is often high because of the environmental benefits, and the R D costs are lower because of the shorter replication cycles in microorganisms and fewer regulatory hurdles. 

The environmental implications of dedicating a lake to mine-waste disposal can be significant. Mining companies proposing subaqueous disposal in natural water bodies face regulatory hurdles, and in some jurisdictions, disposal of mine wastes in natural water bodies is not permitted. In addition, mine sites may be remote from water bodies that have the size or depth to accommodate the mass of mine wastes generated through... 

The industrial scale-up of enzymatic technology is both highly complicated and expensive. Moreover, a primary regulatory hurdle will involve demonstrating that the end products of the cholesterol-enzyme reaction and the novel compounds formed through genetic engineering are harmless. 

Regulatory-Nutritional. Many of the processes for cholesterol removal will meet with regulatory hurdles because of residues, unapproved additives, or byproduct formation. But the real burden for the U.S. dairy industry was the 1993 Nutritional Labeling and Education Act (54). This act created commercial prohibitions,... 

Over the years other carbohydrates have been suggested to replace nutritive monosaccharides in food systems. For example, L-sugars have been proposed [43,44] as useful low calorie and slowly metabolized saccharides. Regulatory hurdles, including demonstrations of safety, generally prove to be formidable barriers to the commercialization of such new materials. L-sugars have not yet been commercialized. 

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