Accelerated drug review

Pharmaceuticals, 18 682-721. See also Food and Drug Administration (FDA) Large-scale pharmaceutical synthesis Pharmaceutical products accelerated development/review for, 18 697... 

Regulations are published to accelerate the review of drugs for life-threatening diseases. 

In some circumstances, the FDA processes drug reviews under the accelerated scheme. This mechanism is to review and approve drugs speedily for cases where effective therapies are lacking or in situations of rare diseases. One of the fastest approval times to date is the case of imatinib mesylate (Gleevec, Novartis—Exhibit 7.3) for the treatment of chronic myeloid leukemia (CML) it was approved in less than 3 months after the filing of an NDA with the FDA. Another example is the new AIDS drug indinavir (Crixivan, Merck), which was approved in a mere 42 days. 

Accelerated Development/Review A drug for the treatment of serious or life-threatening diseases for which there are no alternative therapies may receive expedited review and approval. A condition for the approval is that the Sponsor undertakes to continue with further clinical trials after approval to confirm the efficacy of the drug. 

In response to demands to accelerate the drug review process, however, the FDA perceived opportunities to use the IND process to improve the chances that the subsequent NDA would answer the essential regulatory questions, or eliminate them by answering these questions... 

The FDA publishes regulations designed to accelerate the drug review process for new drugs developed to treat life-threatening diseases. 

The FDA can grant accelerated development/review status to INDs that fit the right profile. A rationale behind the accelerated review option is that adverse drug effects are less of a concern for critically ill patients. While the accelerated status can shorten the approval timeline, the FDA requires more extensive postapproval testing (phase IV) for an accelerated drug. 

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. 

Accelerated development/review can be used under two special circumstances (1) when approval is based on evidence of the product s effect on a surrogate end point, and (2) when the FDA determines that safe use of a product depends on restricting its distribution or use. A surrogate end point is a laboratory finding or physical sign that may not be a direct measurement of how a patient feels, functions, or survives, but it is still considered likely to predict therapeutic benefit for the patient. The fundamental element of this process is that the manufacturers must continue testing after approval to demonstrate that the drug indeed provides therapeutic benefit to the patient. If not, the FDA can withdraw the product from the market more easily than usual. 

Accelerated development/review (Federal Register, April 15,1992) is a highly specialized mechanism for speeding the development of drugs that promise significant benefit over existing therapy for serious or life-threatening illnesses for which no therapy exists. This process incorporates several novel elements... 

The patent extension benefit has become somewhat moot, however, beoause of an overall reduction in U.S. FDA review time as a result of presoription drug user fees. In 1992, Congress passed the Prescription Drug User Fee Aot (PDUFA). The Aot was intended to help the U.S. FDA generate additional funds to upgrade and modernize its operations and to accelerate drug approval. It authorized the U.S. 

There are various ways in which CMEs can benefit analytical applications. These include acceleration of electron-transfer reactions, preferential accumulation, or selective membrane permeation. Such steps can impart higher selectivity, sensitivity, or stability to electrochemical devices. These analytical applications and improvements have been extensively reviewed (35-37). Many other important applications, including electrochromic display devices, controlled release of drugs, electrosynthesis, and corrosion protection, should also benefit from the rational design of electrode surfaces. 

The Food and Drug Administration Modernization Act reauthorizes PDUFA and mandates accelerated reviews and regulates drug advertising of unapproved uses. 

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