Alert

Recommended Alerts

Sign Up For Alerts

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.

Read More

SEC Settles Cases Alleging Compliance Failures at Private Equity Firms


Time to Read: 1 minutes Practices: Government Enforcement / White Collar Criminal Defense, Hedge Funds, Investment Management, Private Equity, Private Funds, Securities & Futures Enforcement

Printer-Friendly Version

On March 11, the SEC announced two matters of significant importance to the private equity industry and to private fund sponsors generally. Together, these cases demonstrate the SEC’s continued focus on the private equity industry, in particular the role of compliance in preventing and detecting possible violations of the securities laws. These cases also reflect the SEC’s interest in monitoring the fundraising activities, valuation practices, and disclosures to investors of private fund sponsors. Although these two matters involved private equity firms, the issues they raised are applicable to a broad range of private fund sponsors, including fund-of-fund and hedge fund managers.

Printer-Friendly Version

Cookie Settings