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The White House said Friday that acting FDA Commissioner Janet Woodcock has not been taken off the list of potential nominees to head the agency despite widespread media reports. Read More
Manufacturers are “already assessing whether they are affected by these vulnerabilities, evaluating the risk and developing remediation actions,” the agency said. Read More
The plan remains contingent on federal review of the safety and efficacy of a third dose of both vaccines, said Surgeon General Vivek Murthy. Read More
By Saturday, states must either sign or reject a proposed $26 billion opioid settlement with the three largest U.S. drug distributors — McKesson, Cardinal Health and AmerisourceBergen — and drugmaker Johnson & Johnson (J&J). Read More
The move comes about a year after Merck asked 340B entities to join a Merck program to provide claims data so the company could prevent duplicative discounts. Read More
The Fast Track designation is reserved for investigational therapies for serious or life-threatening conditions that could address unmet medical needs. Read More
The FDA’s ability to monitor drug facility compliance in fiscal year 2020 was significantly impacted by COVID-19, with only 745 inspections completed for the year vs. 1,367 in fiscal 2019. Read More
Reports of a vulnerability in the Blackberry operating system used in some pharmaceutical manufacturing equipment as well as in certain medical devices and device manufacturing has prompted the FDA to issue a cybersecurity alert. Read More
The Sackler family may withdraw from a proposed settlement to pay more than $4.3 billion to resolve thousands of lawsuits alleging their company Purdue Pharma helped fuel the nationwide opioid epidemic unless the family is granted legal immunity from current and future complaints. Read More