A number of US government officials unanimously predicted a dramatic increase in the number of criminal prosecutions of individuals for violations of laws governing Food and Drug Administration-regulated industries, at a recent Food and Drug Law Institute (FDLI) conference held in Washington DC.
They also discussed how the types of prosecutions may be shifting away from charges based on off-label promotion of drugs and medical devices to charges based on threats to the safety and efficacy of FDA-regulated products, reported Douglas Farquhar of law firm Hyman, Phelps & McNamara - who co-chaired the conference - on the firm’s FDA Law Blog.
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