Removal Of Outdated FDA Inspection Scheduling Rule Blocked By A Few Individuals
It may have seemed like a ‘no brainer’ for FDA to immediately remove the outdated two-year inspection requirement for biologics facilities, but the agency will trudge through the full rulemaking process instead owing to what it called ‘significant adverse comment.’ Such a slow turning of bureaucratic gears might not bode well for the Trump administration’s regulatory reforms.
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But even though executive order that requires regulatory off sets may only have limited application to FDA, limited, experts warn that it still could prove extremely unwieldly to implement.
FDA made request after finding unacceptable levels of nitrosamine NDMA can form during storage above room temperature or beyond expiry. Forthcoming guidance on detecting impurities like nitrosamines in any drug will call for routine testing as well as a chemical risk assessment “to look at what is the probability of generating them.