News & Analysis as of

Enforcement › Final Guidance

Sheppard Mullin Richter & Hampton LLP

Finally, FDA’s Final Word on Unapproved Use Communications

Sheppard Mullin Richter & Hampton LLP on

On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...more

Latham & Watkins LLP

FDA Finalizes Guidance on Communications of Scientific Information on Unapproved Uses

Latham & Watkins LLP on

The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the...more

Foley & Lardner LLP

Scientific Information on Unapproved Uses of Medical Products: FDA’s Final Guidance on Firm Communication to Health Care Providers

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry titled, “Communications From Firms to Health Care Providers Regarding Scientific Information...more

Mintz - Employment Viewpoints

Update: EEOC Issues Final Guidance on Workplace Harassment

Mintz - Employment Viewpoints on

The United States Equal Employment Opportunity (“EEOC”) has issued its final guidance on “Enforcement Guidance on Harassment in the Workplace,” the first of its kind in over 20 years. This final guidance builds on a variety...more

Venable LLP

Crystal Clear: New Guide on Third-Party Risk Management for Community Banks - and Others

Venable LLP on

It is no secret that the Federal Reserve, the FDIC, and the OCC have zeroed in on banks' use of third parties for products, services, and other operations, the risks those arrangements may pose, and banks' responsibility to...more

Skadden, Arps, Slate, Meagher & Flom LLP

Key Questions Remain Despite FDA Attempts To Clarify Guidance on Clinical Decision Software

Skadden, Arps, Slate, Meagher & Flom LLP on

Clinical decision support (CDS) software has been recognized — including by government agencies — as having significant potential to increase quality of care and enhance health outcomes, and companies across the health care...more

Eversheds Sutherland (US) LLP

The IRS is sending warning letters to more than 10,000 virtual currency owners

Eversheds Sutherland (US) LLP on

On July 26, 2019, the IRS announced that it has begun to send letters to more than 10,000 taxpayers who might have failed to report income and pay the resulting tax from virtual currency transactions or who did not report...more

King & Spalding

NHTSA Releases Guidance on Enforcement of Safety-Related Defects in Automated Vehicle Technologies - Agency’s stance raises...

King & Spalding on

Last week, the National Highway Traffic Safety Administration (NHTSA) released its final Enforcement Guidance Bulletin on Safety-Related Defects and Automated Safety Technologies. The Guidance makes clear that the agency’s...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Changes to Obligations for Filing H-1B Amendment Petitions Under Matter of Simeio Solutions, LLC

Ogletree, Deakins, Nash, Smoak & Stewart,... on

As of August 19, 2015, full enforcement of a recent Administrative Appeals Office (AAO) decision in Matter of Simeio Solutions, LLC, 26 I&N Dec. 542 (AAO 2015) will commence. On April 9, 2015, the AAO—the appellate body...more

9 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide