The FDA’s drug approval process
provides a review of product-specific
information that is critical to ensuring
the safety and efficacy of a finished
drug product. For instance, the applicant
must demonstrate that its
manufacturing processes can reliably
produce drug products of expected
strength, quality, and purity and identify
appropriate storage conditions to
maintain drug quality. Furthermore,
FDA’s review of the applicant’s labeling
ensures that health care
professionals and patients have the
information necessary to understand a
drug product’s risks and its safe and
effective use.
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