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Zdrowie i gospodarka · 21.10.2003

Statement of Work for the Evaluation of First Cycle Review Performance; Availability

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Statement of Work for the Evaluation of First Cycle Review Performance." FDA requests comment on the document, which describes a study to evaluate issues associated with FDA's conduct of first cycle reviews of new drug applications (NDAs), biological license applications (BLAs), and efficacy supplements. FDA intends to award a contract to an independent expert consultant that would include, among other tasks, the performance of such a study. The document, as currently written, will be included in the Request for Proposal (RFP) as a sample statement of work. However, prior to actually assigning the task under the contract, FDA intends to finalize the statement of work after considering all received comments.

Source: Federal Register — Food and Drug AdministrationOpen original release →