| http://www.w3.org/ns/prov#value | - new drug applications (ANDA), investigational device exemption (IDE) applications, 510(k) applications, pre-market applications (PMA), and investigator/sponsored initiatives Defend and negotiate resolution or corrective action plans for on-site inspections conducted ??? and sanction actions imposed ??? by the FDA and other regulatory agencies Develop and implement FDA compliance programs with resp
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