$VXRT From the FDA. For drugs granted accelerated approval, postmarketing confirmatory trials have been required to verify and describe the predicted effect on clinical benefit. These studies should usually be underway at the time of the accelerated approval, 21 CFR Part 601, Subpart E, and must be completed with due diligence (section 506(c)(3)(A) of the FD&C Act (21 U.S.C. 356(c)(3)(A)) and 21 CFR 601.
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@Flakz2020 Shelf life quality and sterile processes and consumables. Quality Control batch after batch, Lot after Lot. Think of how many points of contacts with liquid injectables.
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