Trying to avoid a CRL? New FDA draft guidance talks benefit-risks on quality assessments
As manufacturing-related issues continue to plague the biopharma industry and lead to dozens or more FDA rejections, or CRLs, each year, the agency on Monday released new draft guidance spelling out how it assesses quality risks, sources of uncertainty, and possible mitigation strategies.
The FDA’s product quality assessment, according to the 12-page draft, determines whether an applicant’s product development studies, manufacturing process, and control strategy will consistently result in a finished drug or biologic of acceptable quality when manufactured at the facilities named in the application.
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