Complete Response Letters In Lieu Of Inspections: What To Expect During COVID-19
If agency has concerns about facilities it cannot inspect, it will generally issue complete responses, Q&A guidance says.
You may also be interested in...
Novartis Counts On Adherence, Access And Affordability To Ensure Inclisiran’s US Success
The company has said coverage under medical benefit could mean $0 copays for many patients, potentially overcoming a hurdle to uptake in the biologic cholesterol market.
US FDA Cautions Against Blaming CRLs On Inspection Delays
Agency revises pandemic inspection guidance to explain CRL ‘non-deficiency’ inspection comments and update industry on remote interactive evaluations and post-COVID-19 inspection priorities.
US FDA Explains Why Remote Interactive Evaluations Guidance Took So Long
Time taken for interagency alignment, lessons learned from foreign counterparts will increase use of remote video tours, say FDA officials..