Every Day Counts for PTE: Court Finds FDA’s Reinterpretation of Testing Phase Arbitrary and Capricious
FDA Law Blog
AUGUST 12, 2024
As with other FDA-regulated products, such as human drugs and medical devices, the “regulatory review period” is composed of a “testing phase” and a “review phase.” In February 2010, an oral formulation of BRAVECTO, a medication to treat and prevent fleas and tick infestation in dogs, was the subject of an INAD submitted to the Agency.
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