CDER To Pilot Test New Framework For Classifying Drug Safety Issues
A recent draft guidance spells out the agency’s proposed approach to classifying significant post-marketing safety concerns for “standard,” “priority” or “emergency” handling. After pilot testing the framework over the next year, CDER intends to develop milestones for regulatory action on safety issues, similar to NDA/BLA action dates under PDUFA.
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For drug sponsors, FDA's revised process could mean more public disclosures about potential safety risks and more regulatory actions to address those risks. CDER seeks to better leverage scientific and regulatory expertise, including in product quality and compliance, in investigating safety signals under the new policy manual, which also includes target timelines for action.
Pharma/biotech stakeholders push FDA for more clarity on its plans to pilot test a new system for classifying significant drug safety issues and timelines for agency action. Questions about public disclosure of FDA’s classification decisions and handling of safety issues across indications also are raised in industry comments on a draft guidance.
A new draft guidance explains the Center for Drug Evaluation and Research’s approach to communicating emerging drug safety information. Since 2010, Drug Safety Communications have replaced a variety of audience-focused tools laid out in a 2007 guidance, but FDA says public health alerts will be used to communicate about products that pose an immediate danger.