Postmarket Safety Signal Evaluation: US FDA ‘MAPPS’ Out New Approach
Executive Summary
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.
You may also be interested in...
Postmarketing Surveillance: Biosimilars, First-In-Class Approvals Will Not Get Extra Scrutiny
Revised document on best surveillance practices for US FDA staff deletes some product categories subject to more extensive monitoring. It also no longer recommends focusing on adverse events reported in a specific population.
US FDA Drug Risk Management Board To Be Lead By CDER Deputy Cavazzoni
CDER Director Woodcock announced that the drug center will soon launch the Drug Risk Management Board, which will coordinate product safety activities among the different offices; Patrizia Cavazzoni, who serves as CDER's deputy director of operations, will chair the board.
US FDA Postmarketing Drug Safety Modernization Plan Will Cut Across Review Disciplines
Detection of nitrosamine impurities in some marketed drugs highlights need for standardized, consistent approach to systematically monitor risks of drugs throughout their lifecycles, CDER’s Janet Woodcock says. Safety monitoring overhaul is lagging behind new drug review modernization effort, but implementation is expected to begin in 2020.