Journal of Pharmacovigilance

United States Food and Drug Administration Postmarketing Adverse Drug Experience (PADE) inspections and the most frequently cited deviations from federal regulations

Conference Series LLC Joint International Event on 7^th Pharmacovigilance & Pharmaceutical Industry

August 22-24, 2016 Vienna, Austria

Kelley M Simms and Namita Kothary

United States Food and Drug Administration, USA

Posters & Accepted Abstracts: J Pharmacovigil

Abstract:

While many common and preventable drug risks are identified and evaluated before a product is approved and marketed, some risks become evident only after a product is marketed and real-world experience with the product is documented. Postmarketing safety data collection encourages informed decision-making that maximizes benefits and minimizes risks to patients. The United States (US) Food and Drug Administration (FDA)â??s Center for Drug Evaluation and Research (CDER) Office of Compliance (OC) Postmarketing Adverse Drug Experience (PADE) team helps promote and protect the public health of the American people by verifying accuracy, reliability and timeline of postmarketing safety-related data submitted to US FDA. Additionally, the PADE team monitors a drug firmâ??s compliance with the PADE reporting requirements (US regulations) set forth by the federal government. During the inspection process, observed deviations from US regulations are documented by the US FDA investigator and tracked by the PADE team. A drug firmâ??s pharmacovigilance or drug safety department should investigate and identify actual and potential causes of PADE non-compliance and implement measures to prevent (re)occurrence by creating corrective actions. The corrective actions should be submitted to FDA, along with the drug firmâ??s response, within 15-days of issuance of a Form FDA 483, Inspectional Observations. The PADE team assesses each observed deviation from the US regulations by reviewing the supporting evidence collected by the US FDA investigator during the inspection, the firm response and any corrective actions.

Biography :

Email: kelley.simms@fda.hhs.gov