FDA Compliance Experts Advise Against Treating Minor Changes As ‘Planned Deviations’
It’s all about change control and risk management, FDA compliance experts tell rapt audience at PDA/FDA conference when confronted with the common practice of planning deviations so that production won’t falter.
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Agency’s revised OOS guidance clarifies positions on outlier test results, averaging of HPLC results and some finer points around OOS questions. These could marginally improve compliance but won’t impact industry with nearly the force of the original 2006 guidance or the 1993 court ruling that preceded it.
Pink Sheet Podcast: FDA User Fee Bill Mark-Up, Postmarket Quality Requirements, Fewer Adcom Meetings
Pink Sheet reporter and editors discuss the first mark-up of the House FDA user fee bill, the likelihood of more postmarketing quality requirements for drug manufacturers, and the significance of the shrinking number of FDA advisory committee meetings.
Stakeholders given one month to weigh in on proposal to allow relaxations introduced in response to COVID-19-related travel restrictions to continue on a routine basis.