The U.S. Food and Drug Administration (FDA) recently released draft guidance that “recommends studies, including comparative in vitro studies, which should be conducted to demonstrate that a proposed generic solid oral opioid drug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

Keeping to our theme of “Sunshine Week”, this post will focus on getting federal executive, legislative and regulatory information. The Public Papers of the President is your one stop shop for recent Presidential information going back to the Presidency of …

Accessing Federal Executive, Legislative and Regulatory Information Read more »