Combination products don’t usually fail because the science is weak, they fail because teams hit avoidable friction: the wrong lead center, unclear expectations across centers, duplicated information, and quality system gaps that surface late. Two [...]

FDA recently issued a draft guidance: “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.” It’s aiming at drug manufacturing sites regulated by CDER/CBER/CVM and lays out what FDA expects [...]