Friday, November 9, 2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen and modernize agency’s oversight and reporting of inspections for sterile injectable drugs

Manufacturing inspections are one of the FDA’s most important tools for ensuring the quality of pharmaceutical products used by American patients. Inspections help us to identify manufacturing issues that could pose potential risks to patients, or problems that could contribute to drug shortages, enabling us to engage manufacturers to address and resolve issues. Because of the importance of the data that we gather from these inspections, there’s increasing need to more efficiently collect and analyze the information we gather during inspections to give us even better and timelier insight on the state of quality in drug manufacturing facilities and promote the ...

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