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FDA GENERICS DIVISION WILL ASSIGN ANDAs BY THERAPEUTIC CATEGORY

Executive Summary

FDA GENERICS DIVISION WILL ASSIGN ANDAs BY THERAPEUTIC CATEGORY to the division's four ANDA review branches and one antibiotic drug branch. According to a recent internal memo outlining the proposed assignment system, the division plans "to devise and implement an assignment system that parallel[s] the ODE I-II [Office of Drug Evaluation] system." The memo, by acting division director Richard Terselic to Acting Director of the Office of Generic Drugs Bruce Burlington, MD, explains that ODE I-II uses "a rather finely tuned scheme for assigning applications on the basis of disease or therapeutic category, and to a lesser extent, families of drug entities." Terselic recognized that the generic drugs division's method of handling ANDAs "is not quite as ordered" as the "specific rationale that provides a guide for assigning new applications" under the NDA process. The new assignment system was devised "as a part of FDA's promises to the Assistant Secretary [of HHS] regarding implementation of the [Office of the Inspector General] vulnerability report" ("The Pink Sheet" Oct. 2, p. 18). A breakout of ANDAs suggests that the proposed system will attempt to divide the applications equally between the four chemistry ANDA review branches (see box below). The antibiotics branch will most likely take on a lesser workload. Based on a count of existing ANDA approvals and pending applications, the division tried to "reasonably divide these applications among our four review branches (and to anticipate creation of a fifth) and also parallel ODE I-II to the greatest practical extent." The generic drug assignment proposal takes into consideration the recently added ANDA review branch IV ("The Pink Sheet" March 12, T&G-10). In a March 26 memo to the division, Terselic announced that Raj Kishore, PhD, was hired as a new chemistry review branch chief. Most recently a reviewing chemist for the Division of Medical Imaging and Surgical and Dental Drug Products, Kishore will take over Jack Meyer's responsibilities as chief of branch I, effective April 23. Meyer, on the other hand, will head branch IV in addition to coordinating the implementation of the new assignment system.
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