Accelerated development/review

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

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. 

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. 

Accelerated development/review can be used under two special circumstances (a) when approval is based on evidence of the product s effect on a surrogate end point, and (b) 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 is still considered likely to predict therapeutic benefit for the patient. 

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... 

Immune reactions can modulate atherosclerosis development (reviewed in ref. 777J nonspecific stimulation of the innate immune system by endotoxin accelerates cholesterol-induced atherosclerosis in rabbits (178). 

The author hopes that this review will accelerate development and increase the quality of structure diagram generation programs. 

Accelerator in Ready-Mix Concrete. Calcium chloride accelerates the set time of concrete giving it a high early strength development. It is not an antifreeze, but by using it duriag cold weather protection can proceed in a timely manner (31—34). In Russia, calcium chloride forms a component of several antifreeze admixtures (33). Reviews of the concerns and possible remedies of calcium chloride corrosion problems in concrete are available (21,35). There is no consensus on what the safe levels of calcium chloride in concrete are. 

The methodology described In this paper has evolved over the past ten years but still remains very elementary It was developed to minimize the exceptional hazards associated with the design and Implementation of accelerated life tests Many accelerated life tests can be characterized as expensive failures, due to the use of poor experimental designs. Inadequate scientific and statistical expertise, and Insufficient peer review prior to Implementation The methodology outlined below Is Intended to reduce such failures ... 

---