Podcast: Unpacking FDA's Final Clinical Decision Support Guidance - Diagnosing Health Care
Wiley Webinar: Biotech Briefings – Interim Update on Regulatory Developments Relevant to Plant Biostimulants
Edible Bites Episode 2: Cannabis and Life Sciences Video Webinar Series
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
The FDA Center for Veterinary Medicine released the Final Guidance for Industry today for its enforcement policy for AAFCO-defined animal feed ingredients. The big news is that FDA will no longer be reviewing the annual list...more
On June 30, the Federal Trade Commission (FTC) and Department of Justice Antitrust Division (DOJ) released their first jointly issued Vertical Merger Guidelines. These Guidelines replace DOJ’s Non-Horizontal Merger Guidelines...more
The Treasury Department released final Opportunity Zone regulations on December 19, which combine and clarify the prior two sets of guidance, as well as an FAQ summary....more
Both the Commodity Futures Trading Commission and the Chicago Mercantile Exchange brought and settled charges against a CFTC-registered floor broker, claiming he engaged in spoofing trading activity on the CME. The two...more
A Summary of Final Guidances for Communications That Are Consistent with FDA-Required Labeling and Communications with Payors - On June 12, 2018, the Food and Drug Administration (FDA or Agency) finalized two draft...more
On June 12, 2018, the US Food and Drug Administration (FDA) finalized its Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers guidance (Final Guidance)....more
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
Amended H-1B Petitions May be Required Immediately - Applies to: All employers with H-1B employees working at job sites other than those specified in H-1B filing. Action needed now: Verify that actual work site of...more