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.
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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.
Singapore recalls trigger international reaction as metformin is added to growing list of chronic medications found to contain NDMA.
The FDA has confirmed the picks to head most of the new offices in the restructured drug review organization, with one notable exception. The choice for the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine is still pending, while one candidate – Hylton Joffe – will be serving as acting OND deputy director.