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A Question of Intent: FDA Amends Intended Use Regulations with Goal to Provide More Clarity, but Significant Questions Remain

On August 2, 2021, FDA issued a final rule amending its drug and medical device regulations describing the types of evidence that FDA considers relevant to determining a product’s “intended use.” The concept of intended use is a cornerstone of FDA’s regulatory scheme that determines whether and how the Agency regulates a product as a drug or device. This final rule represents the culmination of a nearly six-years-long rulemaking process that generated extensive comments from stakeholders. Most significantly, the final rule clarifies that a firm will not be regarded as intending an unapproved new, or off-label, use for a drug or device based solely on that firm’s knowledge that the product was prescribed or used by health care providers for the use. More generally, FDA has made clear that it will continue to take a broad view of what evidence, including manufacturer communications and other information about the product, may be considered when determining intended use. The amended regulations also will expressly state for the first time that the “design or composition” of an article may be relevant to determining intended use.

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Legal Advice Privilege – HK Court of Appeal Steers Away from Three Rivers


Time to Read: 1 minutes Practices: Government Enforcement / White Collar Criminal Defense

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On June 29, 2015, the Court of Appeal of the HKSAR handed down an important judgment relating to legal advice privilege. 

The Court of Appeal decided to adopt the “dominant purpose test” when considering whether legal advice privilege should attach to a document that disagrees with the restrictive definition of “client” adopted by the English Court of Appeal in the case of Three Rivers (No.5)

Consequently, whether legal advice privilege applies to an internal confidential document depends on whether it was produced or brought into existence with the dominant purpose that the document or its contents be used to obtain legal advice. The judgment is likely to be broadly welcomed in the in-house legal community. 

The case is Citic Pacific Limited v. Secretary for Justice CACV 7/2012, and the judgment is available on the Hong Kong Judiciary website here.


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