CDER Safety Overhaul Planned As Review Process Modernization Continues
US FDA's Woodcock tells the Pink Sheet that goals include eliminating duplication through creation of one safety review process.
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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.
US FDA Looks To Standardize Premarketing Safety Assessments
Ellis Unger tells the Pink Sheet that Premarket Safety Assessment Working Group is overseeing various projects aimed at bringing more standardization to NDA and BLA safety assessments across applications and review divisions, while also bolstering the quality of those reviews; initiatives include development of queries that group similar types of adverse events together and standardizing the safety information requested at pre-NDA meetings.
Four Rules For Being A Consistent US FDA Reviewer From Peter Stein
Amid concerns Office of New Drugs reorganization will result in sponsors receiving conflicting advice, new director offers several items already contemplated to prevent such problems.