FDA Guidance Urges Vigilance to Fight Suspect Products in Drug Supply Chain

Overview


Karen Owen Gibbs said that new FDA guidelines will “provide some specific examples and contexts for when manufacturers should find substantial risk of [product] illegitimacy,“due to tampering or counterfeiting. Ms. Gibbs added the FDA “is putting manufacturers and other trading partners on notice that it expects them to go beyond their own activity…and be aware generally of what may be happening in the market.”