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The Silver Sheet” In- depth analysis of medical device quality control issues that are now part of " The Gray Sheet". Archived content is available here. 483’ s / Warning letters related to. • FDA expanded its inspection team in India from 12 to 19. analyst' s notebook and the Calculation Sheet.
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FDA was close to issuing a draft guidance on the application requirements for follow- on biopharma- ceuticals last spring ( “ The Gold Sheet” January ), but has delayed doing so to accommodate further exploration of the issues at the workshops. FDA is also delaying regulatory decisions on applications.