JD Supra

FDA Finally Finalizes the Intended Use Rule

Last week, FDA published its new final rule amending the “intended use” regulations for drugs and medical devices, which it hopes will “put to rest any dispute” about the agency’s interpretation of ...
Variety

The Intended

Another ferocious perf by Janet McTeer and an atmospheric Malaysian jungle location are nearly lost in the DV muddiness of period drama "The Intended." Clearly intending to amplify the themes of ...
JD Supra

FDA Proposes to Revise “Intended Use” Regulations (Again) to Clarify that Knowledge Alone Is Not Sufficient to Establish Intent

“Intended use” is perhaps one of the most important concepts in FDA law. It is significant in two ways. First, a product’s intended use can dictate whether it is even subject to regulation by FDA, and ...
Law

The Impending Demise of the Intended Loss Doctrine in Federal Sentencing

Federal sentencing can seem unjustly harsh. Consider the following hypothetical: A defendant in a health care case is charged with conspiracy to commit health care fraud and five substantive counts of ...