Postmarketing Safety: US FDA ‘Best Practices’ Include Weekly Adverse Event Screening For New Drugs
Agency’s approach to risk-based postmarketing safety surveillance explained in new draft document issued under the 21st Century Cures Act; product characteristics and intended use guide the frequency and extent of adverse event report screening, with newer drugs undergoing weekly reviews for three years after approval.
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Postmarket Safety Signal Evaluation: US FDA ‘MAPPS’ Out New Approach
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.
FDA Budget Request Proposes OTC Monograph User Fees And ‘Field Alerts’
In addition proposing $28.4m in monograph user fees, agency’s FY 2021 budget justification includes among its legislative initiatives proposing to require "Field Alert Reports" for drug products not marketed under an approved application, such as monograph OTCs.
Sharfstein: US FDA Incentives Not Broke, But Fix Them
The former US FDA principal deputy commissioner argues that accelerated approval, fast track and breakthrough designation standards may need updating, along with orphan and pediatric exclusivity requirements, to enhance the programs' efficacy.