Traditional drug licensing approaches are based on binary decisions. At the moment of licensing, an experimental therapy is presumptively transformed into a fully vetted, safe, efficacious therapy. By contrast, adaptive licensing (AL) approaches are based on stepwise learning under conditions of acknowledged uncertainty, with iterative phases of data gathering and regulatory evaluation. This approach allows approval to align more closely with patient needs for timely access to new technologies and for data to inform medical decisions. The concept of AL embraces a range of perspectives. Some see AL as an evolutionary step, extending elements that are now in place. Others envision a transformative framework that may require legislative action before implementation. This article summarizes recent AL proposals; discusses how proposals might be translated into practice, with illustrations in different therapeutic areas; and identifies unresolved issues to inform decisions on the design and implementation of AL.

CC-1065 (NSC 298223) is a potent new antitumor antibiotic with a unique structure produced by Streptomyces zelensis. Improved production, isolation, and assay methods are described along with physico-chemical properties and antitumor activity. Screening for soil cultures producing agents displaying both cytotoxic activity against L1210 cells in culture and in vivo activity against P388 leukemia in mice afforded a culture, Streptomyces zelensis, producing a new, potent antitumor antibiotic, CC-1065. Its production, in vitro biological activity, microbiological assays, and taxonomy have already been described1) ; a preliminary communication announced the structure2) shown in Fig. 1. Details of the structure determination have recently been described3). A molecular model of CC-1065 displayed a remarkable curvature, shape,

No abstract

No abstract

No abstract