Removal Of Outdated FDA Inspection Scheduling Rule Blocked By A Few Individuals

06 May 2018

It may have seemed like a ‘no brainer’ for FDA to immediately remove the outdated two-year inspection requirement for biologics facilities, but the agency will trudge through the full rulemaking process instead owing to what it called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.

ine conveyor for labeling and packaging ampoules in boxes

It will be slow going for the Trump administration’s regulatory reform agenda if FDA’s decision to withdraw a direct final rule on inspection scheduling for biologic drug products is any indication.

FDA cites “significant adverse comment” in a May 7 Federal Register notice for its decision to withdraw the direct final...