Manufacturing Regulatory Updates In Brief
FDA's “Wayback” archive; EMA's whistleblower policy; IPRF's drug ID plan; reprieve for DMF holders; investigational compounding; PK/PD for kids; ISPE on quality culture; PDA on quality risks.
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Followers of rogue FDA twitter site AltFDA answered a call to back up inspection citations data the Obama administration made public in case the Trump administration erases it from the FDA website.
An excipient trade group said that converting paper drug master files to electronic DMFs is fraught with challenges and suggested some alternatives to ease the path for communicating proprietary information to US FDA. Agency guidance has set a May 5 deadline for conversion to eDMFs.
A fresh executive order from US president Joe Biden calls for short-term and long-term study, broad consultation, and co-ordination with allies on the domestic supply chain.