FDA’s Safety Reporting Requirements: Developing a Compliant Pharmacovigilance Plan
If you’re feeling the pharmacovigilance heat, you’re not alone. The FDA has stepped up its scrutiny of your reporting and made the process more complex. And it is signaling there’s more to come.
To stay compliant, you need 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 you to do both.
The terms, definitions, reporting processes and timelines the FDA sets out are all very specific … and often confusing. Failure to comply with pharmacovigilance regulations can lead to regulatory action by the FDA — withdrawal or suspension of approval, even product recall.
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 you must know about COVID-19’s immense effects on pharmacovigilance and looks ahead to the FDA’s next likely steps: new guidances, initiatives and more. All so you can stay compliant.
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 you 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.
About the Contributor
Beth Packman Weinman, counsel, is a member of Ropes & Gray’s life sciences regulatory and compliance practice group. She focuses her practice on FDA regulation and enforcement of laws governing pharmaceuticals, biologics, medical devices and foods, including dietary supplements. Ms. Weinman represents clients in False Claims Act (FCA) and Federal Food, Drug, and Cosmetic Act (FDCA) investigations and other enforcement actions before state and federal regulators, and also represents clients in administrative litigation matters. In addition, she provides counseling on issues related to marketing practices, current good manufacturing practices, good clinical practices, compounding, medical product development and approval, and product recalls and withdrawals. Prior to joining Ropes & Gray, Ms. Weinman spent nearly eight years as associate chief counsel for enforcement within FDA’s Office of Chief Counsel.
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