Fast track

SEC. 505B. RESEARCH INTO PEDIATRIC USES FOR DRUGS AND BIOLOGICAL PRODUCTS. SEC. 506. FAST TRACK PRODUCTS. 

Fast-track registration systems now exist in Australia, Cypms, Estonia, Malaysia, the Netherlands, Tunisia and Zimbabwe (see Table 8.1), although probably not all of them were established as a result of political pressure. Different fast-track systems serve different purposes. In Australia, Cypms and Malaysia, fast-track registration is intended to facilitate the assessment and registration of new dmgs for treating serious, life-... 

In Venezuela, there is no official fast-track system. However, brief-mode registration is available for generic products for which a bioavailabilily study has been undertaken. Similarly, Malaysia has an abridged procedure for registration of products classified as non-scheduled poisons. This type of simplified procedure does not, in essence, differ from the use of less stringent registration requirements for certain categories of products as seen, for example, for herbal medicines in Australia and the Netherlands. 

Months taken to assess fast-track products N/A N/A 3 1 6 2 3 6 1 6... 

Fast Track Media LLC. (2007) SC Johnson Makes Greenlist Available Royalty-Free. [Online -accessed 1 May 2007] Available from URL http //vww.environmentaUeader.eom/2007/02/22/sc-johnson-makes-greenlist-available-royalty-free/... 

As noted in Chapter 1, the priorities in batch processes are often quite different from those in large-scale continuous processes. Particularly when manufacturing specialty chemicals, the shortest time possible to get a new product to market is often the biggest priority (accepting that the product must meet the specifications and regulations demanded and the process must meet the required safety and environmental standards). This is particularly true if the product is protected by patent. The period over which the product is protected by patent must be exploited to its full. This means that product development, testing, pilot plant work, process design and construction should be fast tracked and carried out as much as possible in parallel. 

When some pharmaceutical products are approved, the FDA will ask the manufacturer to commit to postmarketing phase IV studies. These studies are mandatory for accelerated approval of products to treat serious and life-threatening illnesses ("fast-track" products) and deferred pediatric studies where safe use in children needs to be clarified. Other studies may be requested by the FDA before or after granting marketing approval if the FDA concludes that additional information is important to the prescribing and use of the product. 

Fast reactors, 17 568 Fast relaxation time, 24 127 Fast Track Drug Approval programs,... 

FDA Center for Food Safety and Applied Nutrition (CFSAN), 23 667 FDA certified colors, 12 35 FDA Fast Track Drug Approval programs, 18 697... 

Willman, D., Rezulin Fast-Track Approval and a slow Withdrawal, Los Angeles, Times, Section Al, December 20, 2000. Fraser, C.G., Adrenal atrophy and irreversible shock associated with cortisone therapy, JAMA, 149, 1542-1543, 1952. 

Clinical Trial Application (CTA) has to be submitted to Health Canada seeking permission to conduct clinical trials. The submission should include information regarding drug characteristics, test data, animal studies, and clinical protocol. A clinical trial may be stopped when either it is shown to be unsafe or dramatic benefits are obtained. The approval process may be fast-tracked if a drug is shown to have substantial benefits, such as for treatment of life-threatening or severely debilitating conditions. 

UPS hires people that will fit into its culture and who will fit into this iterative improvement and measurement work place. Remember, the people that UPS avoids are those wanting a fast track to the top. UPS is looking for those who want to be part of a team that is the best at what it does and who love the blocking and tackling of business. The payoff for a job well done is the opportunity to... 

One solution might be to initially scrutinize proposals from investigators who lack a solid track record, and then to give a less stringent review as the performance improves. But today s bureaucrats seem inclined to go slow in all matters, preferring to head off one questionable study than to fast-track a hundred well-designed studies by established researchers. 

The phase-three results were unblinded in March 2003 and overall, for all types of metastatic brain cancer, were reported as nonpositive, showing the drug to have efficacy but not at the statistical level set at the beginning of the trial by Alios Therapeutics Inc. for a successful phase-three trial. The subset analysis for the different types of metastatic cancer to brain, however, showed that breast cancer patients had a 100% increase in survival. The 500 plus patient trial also demonstrated RSR 13 to be extremely safe, confirming our early design feature of using a known antilipidemic drug, clofibrate, as a substructure. An NDA for RSR 13 with trade name efaproxaril was reviewed by the PDA on a fast track review for use in treatment of metastases of breast cancer to brain. 

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