Manufacturing Regulatory Updates In Brief
Executive Summary
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.
You may also be interested in...
Rogue FDA Tweeters Archive Inspection Data, Fearing Deletion By Trump
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.
Why Excipient Suppliers Should Dump Most DMFs Prior To May Deadline
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.
‘Shadow’ Factory Challenges Continue For US FDA
Agency wants more information about API suppliers as it winds up case against KV Tech for hidden use of Dr. Reddy’s plant and seeks to find disappearing manufacturer of contaminated OTC eye drops.