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FDA Commissioner Stephen Hahn offered more details yesterday of the agency’s plans to request paper records from Chinese drugmakers and API manufacturers while inspections in China are on hold during the COVID-19 outbreak. Read More
The first U.S. clinical trial of a treatment for COVID-19 — Gilead’s antiviral remdesivir — has begun at the University of Nebraska Medical Center in Omaha. Read More
Mallinckrodt announced a $1.6 billion settlement with 47 U.S. states and territories for its role in the nation’s opioid crisis, in a deal that involves the bankruptcy of its generics unit. Read More
The White House has asked Congress for $2.5 billion in emergency funding to support the government’s response to the coronavirus outbreak — including more than a billion dollars for vaccine development — as a senior CDC official predicted a “community spread” of the virus in the U.S. Read More
A blockchain-based drug tracking network is capable of meeting future supply chain regulatory requirements, according to pharma companies that took part in a pilot program run by the FDA. Read More
The FDA released a new version of its Purple Book for biological product developers in a searchable database that links each biosimilar and interchangeable with its reference product. Read More