Tag Archives: FDA

FDA’s Proposed Rule on “Intended Use” Confirms Agency Will Rely on “Any Relevant Source” of Evidence

On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to modify its intended use regulations.  In its current form, the regulations have created long-standing confusion as to whether mere knowledge of an unapproved use of an approved product (i.e., off-label) automatically triggers a new “intended use,” for which clearance or … Continue Reading

FDA Postpones Ex-US Facility Inspections

U.S. Food and Drug Administration (FDA) Commissioner Stephen M. Hahn, M.D., announced that FDA is postponing foreign inspections through April 2020 in response to the COVID-19 outbreak.  Manufacturers, including contract manufacturers, anticipating post-approval inspections may welcome the news, given other pressing issues facing ex-US facilities (i.e., facilities located outside the US) in light of COVID-19.  … Continue Reading

FDA Issues Warning Letter to Lab Marketing Three Laboratory-Developed Tests

In an April 4, 2019 Press Release, the U.S. Food and Drug Administration (FDA) announced its issuance of a Warning Letter to Inova Genomics Laboratory (Inova) in Virginia for marketing genetic tests for predicting medication response and patient receptivity to drugs (among other things). FDA identified three genetic tests, including one called “MediMap Plus,” which … Continue Reading
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