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The FDA’s Center for Drug Evaluation and Research (CDER) is setting up a new board to strengthen pharmaceutical supply-chain monitoring in the wake of COVID-19-related drug shortages, CDER Director Patrizia Cavazzoni announced on Friday. Read More
Federal officials are said to be examining whether Moderna’s COVID-19 vaccine is linked with higher risks of heart inflammation in younger people than once thought, possibly delaying the shot receiving authorization for adolescents. Read More
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