The U.S. Food and Drug Administration (FDA) recently released draft guidance that “recommends studies, including comparative in vitro studies, which should be conducted to demonstrate that a proposed generic solid oral opioid drug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

Are you working this summer?  Summer associates and clerks are often assigned research tasks dealing with administrative law and legislative history.  Are you prepared? No worries! Come to the Administrative Law & Legislative History Research Law Library Research Certificate Seminar …

Administrative Law & Legislative History Research Certificate Seminar this Thursday 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 »