This week the US Food and Drug Administration (FDA) released its draft guidance on how to advance risk-based inspections and improve issues with drug shortages. Earlier this year, FDA created the Office of Pharmaceutical Quality (OPQ) to help look at drug product and quality level. Many drug shortages are caused by manufacturer quality issues. The creation of the new office hopes to curtail future shortages and problems.
The new draft guidance aims to not only improve the quality of drugs, but decrease the amount of inspections needed.
To read more, check out Michael Mezher’s article in RAPS here.