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FDA Commissioner Stephen Hahn said the agency is taking a “forward-leaning approach” to identify supply chain shortages caused by the coronavirus outbreak and isn’t waiting around for drugmakers to report them. Read More
Nearly 600 pediatric drugs across various therapeutic areas are currently being tested in clinical trials, according to a report from the Pharmaceutical Research and Manufacturers of America (PhRMA). Read More
A federal appeals court in Ohio stayed an order requiring pharmacies to submit 14 years of nationwide opioid dispensing data in the state’s ongoing multi-district opioid litigation, limiting the scope to just the state of Ohio. Read More
CBER unveiled its guidance agenda for the 2020, including planned draft guidances on gene therapy for neurodegenerative diseases, CAR-T cell therapies and genome editing. Read More
Purdue Pharma has requested permission from the U.S. Bankruptcy Court for the Southern District of New York to develop a new product to reverse opioid overdoses. A hearing before the court has been set for Feb. 21. Read More
In observance of Presidents' Day, Drug Industry Daily will not be published Monday, Feb. 17. The next issue will be published Tuesday, Feb. 18. Read More