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The FDA denied a petition from Pharmaceutical Manufacturing Research Services (PMRS) asking the agency to set a higher standard for NDAs for abuse-deterrent opioids for treatment of chronic pain. Read More
Former Insys CEO Michael Babich has agreed to plead guilty in connection with a kickback scheme involving the company’s Subsys fentanyl spray, the U.S. Attorney for the District of Massachusetts said in a court filing this week. Read More
Some supporters of co-prescribing said labeling could help reach high-risk populations, while others questioned the effectiveness of labeling versus other approaches. Read More
Leading drugmakers are urging the FDA to think bigger about its master protocol guidelines for clinical trials and expand beyond cancer trials. Read More
The Justice Department took back nearly $3 billion through judgments and settlements in fraud and false claims cases in fiscal year 2018 — with $2.5 billion of the recoveries involving the healthcare industry, including drugmakers, pharmacies and physicians. Read More
The investigation found breakdowns within the distributors’ anti-diversion strategies and serious failures to report suspicious drug orders by individual pharmacies. Read More