Compounder Inspections: States Press FDA For Greater Frequency
FDA says the user fee framework allows for risk-based scheduling of compounder inspections about every three years, but some state officials told the agency they want them inspected every six months to a year.
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Virtual kick-off meetings may be necessary, but preparations continue in anticipation of the formal talks to reauthorize the prescription drug, generic drug and biosimilar user fee programs.
Agency officials can now discuss the ideas that have been accepted, though not in great detail.
Likelihood of webcast-only advisory committee meetings may depend on the extent of the coronavirus outbreak, Office of New Drugs Director Peter Stein tells the Pink Sheet in an interview.