FDA Logo

FDA Guidance Looks to Boost Generic Drug Trials

In an effort to help speed generic drugs to market—especially those addressing the opioid crisis—the U.S. Food and Drug Administration (FDA) has issued 43 new guidances, including 26 aimed at specific drugs and 17 revisions to update and streamline the generic drug trials process. “These updated guidances will make the process for developing low cost, […]

Dr. Larry Kennedy, VP for Quality Management Systems and Chief Quality Officers, ACRES

ACRES Unveils Clinical Research Site Accreditation Standards

Years in the making, with dozens of experts and entities engaged in the back and forth discussions, the Alliance for Clinical Research Excellence and Safety (ACRES) just unveiled a global quality standard for clinical research sites aimed at raising the accuracy and integrity of data input from the very beginning of the process. Too often, […]