Fast-Track Products

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

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

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. 

Concurrently with an IND filing (or at any later time), a sponsor can request a fast-track product designation for its drug, provided the therapy addresses unmet medical needs related to a serious and life-threatening condition. This fast-track designation, which was created under the FDA Modernization Act of 1997, makes a product eligible for accelerated approval and other benefits. 

Sub-Part E. 21CFR312.80-88 ( Sub-Part E ) also provides for expedited approvals, when reviews can be accelerated for drugs intended to treat life-threatening and severely debilitating illnesses . This is generally understood to be disease states where there is no effective, alternative therapy. Sub-Part E anticipates flexibility, but continued observance of the statute, as for all drugs. Such products are officially termed Fast Track Products . The target NDA review time is reduced from the ordinary 10 months to 6 months under these provisions. 

As a dynamic international scientist and businessman. Dr. Knablein served as consultant for global players, among them Baxter, Hoechst and Elan Pharmaceuticals focusing on fast-track product development, time-to-market reduction and imple-... 

Miravant Medical Technologies (2000). FDA designates Miravant s Purlytin as fast track product for macular degeneration. Press Release, 5 May. 

Such products are officially termed Fast Track Products . 

Short life cycles require a demand chain to be able to fast track product development, manufacturing and logistics to exploit ever decreasing windows of opportunity. 

In situations like this the time available to develop new products, to launch them and to meet marketplace demand is clearly greatly reduced. Hence the ability to fast track product development, manufacturing and logistics becomes a key element of competitive strategy. Figure 6.2 shows the effect of being late into the market and slow to meet demand. 

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. 

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. 

Brush, P.N. November 1983. "Fast Track for PCBs." Product Finishing. Pp. 84-5. 

In 2001 Sharpless proposed this method - in which smaller units are joined together by way of heteroatom bonds (C-X-C X=heteroatom) - as a fast track route to compounds [16]. The criteria for a click reactiorf were recently summarised broad applicability with high yields readily accessible starting compounds readily separable by-products or none at all straightforward reaction conditions easy product isolation stereospecific... 

Fast track program This program was added under the FDA Modernization Act of1997 as an extension of the accelerated drug and biologic product approval process. It was designed to facilitate development and expedite review for products that demonstrate potential or unmet medical needs in the treatment of serious or life-threatening conditions. 

Other proposed changes to the drug approval process would include increased centralization of drug approvals, with more new products being submitted to the EMEA, fast-track approvals for drugs intended for poorly treated diseases, and compassionate use of unapproved drugs where no alternative exists [114]. 

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