FDA’s New ‘Site Engagement’ Program Aims To Avert Quality-Related Drug Shortages
US FDA office that surveils drug manufacturing facilities invites sites on the cusp of failure for “engagements” in which they talk about how to turn things around. The agency says there’s no pressure – these site engagements aren’t enforcement actions and they’re completely voluntary.
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The head of US FDA’s drug quality office comments on quality-related topics at the GRx-Biosims meeting; sheds more light on facility rating system plan.
'Concept of Operations' document spells out how FDA's realigned inspectorate and program offices will work together to accelerate drug manufacturing facility evaluations and inspections in line with generic and brand drug product reviews. Under the new approach, the agency expects to produce establishment inspection reports, facility classifications and warning letters more quickly, giving applicants more time to avoid manufacturing-related complete response letters.
How FDA Will Use Its New Authority against Denying, Limiting or Refusing Inspections – And Why Industry is Still Worried
How will FDA use its recently drafted guidance against obstructing inspections? Industry fears it may depend on how individual investigators interpret terms like “reasonable.”