Within their overview for reporting requirements, the FDA provided key considerations for the topics of: timescales of new drug applications (NDA), abbreviated new drug applications (ANDA) and biologics license applications (BLA) PMR and PMC status categories and additional requirements involved with post-marketing reporting requirements.
Additionally, the report went into further detail for the reasons why and circumstances where the FDA can require applicants and license holders to conduct clinical and post-marketing activities, in the interest of ensuring both patient and subject safety. In summary of their annual report, the FDA has outlined that Pharma Companies can have either a post-marketing requirement (PMR) or a post-marketing commitment (PMC) in place. The Food and Drug Administration (FDA) has published their report on the performance of industry organisations in fulfilling their drug safety reporting requirements.
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