Kim Schroer

Jun 22, 2023 | pharmaceuticalonline.com | Donielle McCutcheon |Kim Schroer |Carol Houts |Satu Lakio

By Donielle McCutcheon and Kim Schroer, Sidley Austin LLP For emerging drug companies on a tight budget, an effective healthcare compliance program can save precious resources by establishing better oversight, controls, and monitoring of the company’s quality, R&D, clinical, and market access activities. Such a program should be implemented in precommercial stages and will prepare you for the regulated future ahead.

Jun 9, 2023 | outsourcedpharma.com | Donielle McCutcheon |Kim Schroer |Louis Garguilo

Guest Column | June 9, 2023 By Donielle McCutcheon and Kim Schroer, Sidley Austin LLP In the rush to obtain final approval or clearance from the FDA, raise funds, develop compelling data, and preserve scarce cash, it can be tempting to put off investment in a healthcare compliance program.

May 31, 2023 | lexology.com | Catherine Y. Starks |Meenakshi Datta |Elizabeth Hardcastle |Donielle McCutcheon |William A. Sarraille |Trevor L. Wear | +2 more

On May 23, 2023, the U.S. Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that addresses a variety of important drug pricing matters under the Medicaid Drug Rebate Program (MDRP).

Feb 8, 2023 | lexology.com | Meenakshi Datta |William A. Sarraille |Trevor L. Wear |Kim Schroer

On January 1, 2023, a longstanding proposal by the Centers for Medicare & Medicaid Services (CMS) to include U.S. territories (American Samoa, Northern Mariana Islands, Guam, Puerto Rico, and the Virgin Islands) in the regulatory definitions of “States” and “United States” under the Medicaid Drug Rebate Program (MDRP) went into effect after several delays.