WCG FDAnews

FALLS CHURCH, Va. (PRWEB)
February 17, 2022

Pharmacovigilance is getting increasingly complex as the FDA intensifies its scrutiny of safety reporting. To stay compliant, one needs to get a handle on the newest requirements and get in front of the agency’s next moves. FDA’s Safety Reporting Requirements: Developing a Compliant Pharmacovigilance Plan enables one to do both.

Compliance begins with clarification: this report makes clear the requirements for reporting adverse events and other safety issues, it identifies the sources of reportable safety information and the forms/online portals used for FDA reporting, and it simplifies records retention requirements and the agency’s periodic adverse drug event inspections program.

FDA’s Safety Reporting Requirements goes further. It sheds light on what must be known about COVID-19’s effects on pharmacovigilance and looks ahead to the FDA’s next likely steps: new guidances, initiatives and more.

Management report takeaways:

• 
  Examples of drug safety reporting that can lead to label changes
• How the FDA uses reports to detect safety signals and how it makes drug safety information available to the public
• When and why there is a postapproval study requirement for drugs subject to accelerated approval
• When reported adverse events might lead to an FDA Safety Communication or a request for a recall
• Record retention requirements
• Making sense of drug safety reporting requirements during COVID-19

Fail to comply with pharmacovigilance regulations and one can face FDA regulatory action or even civil or criminal enforcement by the Department of Justice. Compliance begins with FDA’s Safety Reporting Requirements: Developing a Compliant Pharmacovigilance Plan.

Management Report Details:

FDA’s Safety Reporting Requirements:

Developing a Compliant Pharmacovigilance Plan

FDAnews Management Report

https://www.fdanews.com/products/62098

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About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations

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