The U.S. Food and Drug Administration (FDA) recently released draft guidance that “recommends studies, including comparative in vitro studies, which should be conducted to demonstrate that a proposed generic solid oral opioid drug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 »