FDA Pulmonary Division label drafting meetings could shave two weeks off review times -- CSO.
FDA PULMONARY DIVISION LABEL DRAFTING PROCESS CAN SAVE TWO WEEKS in completing the review of NDAs, Pulmonary Drug Division Supervisory Consumer Safety Officer Cathie Schumaker told a Regulatory Affairs Professional Society meeting in Washington, D.C. Sept. 19. Instead of passing draft labeling from reviewer to reviewer, each of whom "takes two or three days to make changes," the division is holding group meetings to edit labeling on a computer screen, Schumaker said.
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