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Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership
As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more
On July 10, 2020, the Food and Drug Administration (FDA or the Agency) announced plans to resume domestic facility inspections following the March 2020 suspension of most foreign and domestic facility inspections as a result...more
On November 9, FDA Commissioner Scott Gottlieb, M.D., announced that the agency launched new inspection protocols for aseptic processing of sterile drugs to be used by FDA investigators during surveillance and pre-approval...more
Under the Trump administration, foreign device manufacturers may see new compliance pressures and increased inspections by the FDA. In this video, Michael Heyl discusses this growing trend and shares insights on how foreign...more
The U.S. Food & Drug Administration (FDA) has released statistics showing that it inspected fewer medical device manufacturers in 2015 than in 2014....more