JD Supra

FDA Announces Guidance for DSCSA Process to Request a Waiver, Exception, or Exemption

On Friday, August 4 th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section ...
JD Supra

Manufacturers Must Request Small Biotech Exception by July 3: Inflation Reduction Act Updates

On June 2, 2023, the Centers for Medicare & Medicaid Services (CMS) issued instructions for the process by which a manufacturer may submit a request for a qualifying single-source drug to be ...
Insurancenewsnet.com

Medicare Program; Approval of Request for an Exception to the Prohibition on Expansion of Facility Capacity Under the Hospital Ownership and Rural Provider Exceptions to the ...

Agency: "Centers for Medicare & Medicaid Services (CMS), HHS." SUMMARY: This final notice announces our decision to approve the request of St. James Behavioral Health Hospital Inc for an exception to ...
Kellogg School of Management

Expense Policy Exceptions

In those instances where requests for travel and other business-related expenses do not conform to stated University policies, an Expense Policy Exception Request Form must be reviewed and signed by ...