The U.S. Food and Drug Administration (FDA) recently released draft guidance that “recommends studies, including comparative in vitro studies, which should be conducted to demonstrate that a proposed generic solid oral opioid drug product is no less abuse-deterrent than its …

FDA Guidance on Generic Abuse-Deterrent Opioid Medications Read more »

Public Citizen’s Health Research Group (HRG) recently filed a civil action in the U.S. District Court for the District of Columbia, under the Freedom of Information Act (FOIA; 5 U.S.C. 552: Public information; agency rules, opinions, orders, records, and proceedings), …

Advocacy Group Sues to Compel DHHS to Release Documents Read more »

Prescription drugs administered in a hospital outpatient department or physician’s office are covered by Medicare Part B. The U.S. Centers for Medicare & Medicaid Services (CMS) just released a proposed rule on a “Part B Drug Payment Model as a …

CMS Seeking Comment on New Ways to Pay for Medicare Part B Drugs Read more »

The U.S. Department of Health & Human Services Office for Civil Rights recently released new guidance on an individuals’ access to their health information – both acquiring copy of such information and providing such information to others, including entities interested …

DHHS Guidance on Individual’s Access to Their Health Data Read more »