Like the FR and CFR that are often used to better clarify or define the intent, expectations, or what is needed or required to comply with or enforce the FDCA, FDA, as already noted, prepares and publishes guidances that provide further insight, direction, and the Agency's current thinking on how to best satisfy the FDCA and FR/CFR rules or regulations, albeit that FDA guidances are not legally binding. FDA guidances also attempt to establish uniformity and consistency as to what is needed in NDAs for submission.5 Key FDA guidances [http://www.fda.gov/cder/guidance] that address different aspects of clinical pharmacology and biopharmaceutics, as previously defined, are covered.
Please note that only the guidances that are posted as "final" on the CDER web page are summarized below and the reader is encouraged to look up guidances that are posted but are at the "draft" stage. Additionally, several of these "final" guidances deal with either a particular drug product or a specific therapeutic area and therefore are not considered in this chapter; only the "final" guidances that cover the general, broad-based principles which apply to majority of the drug products and therapeutic areas are summarized below.
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