Archive for November 2018

The FDA granted orphan status to 26 drugs whose applications didn’t include all required information, , according to a Government Accountability Office report released on Friday. Source: Drug Industry Daily

As part of its efforts to contain the opioid epidemic, the U.S. Attorney for the District of Massachusetts issued warnings to opioid prescribers whose patients died of overdoses. Source: Drug Industry Daily

Sen. Jeff Merkley (D-Ore.) introduced the Low Prices Drug Act (S.3680) — a bill that would tie drug prices to drugmakers’ access to Medicare and Medicaid patients and align U.S. drug prices with those in other developed countries. Source: Drug Industry Daily

The FDA announced plans Friday to collaborate with the World Health Organization (WHO) under a pilot program aimed at speeding up reviews of HIV drug applications. Source: Drug Industry Daily

In a wide-ranging analysis of ways to improve access to cancer drugs, the World Health Organization found the drugs remain costly even in countries with strict drug pricing regulations, price transparency is desirable but won’t really address high prices, and initiatives like value-based pricing may not be all that its advocates promise. Source: Drug Industry…

The FDA has agreed to recognize drug and active pharmaceutical ingredient GMP inspections carried out by authorities in Belgium, Denmark, Finland, Latvia and Estonia, updating the 1998 mutual recognition agreement between the U.S. and the European Union. Source: Drug Industry Daily

Virginia Attorney General Mark Herring led 22 state attorneys general in filing an amicus brief urging the Supreme Court to uphold states’ right to hold drugmakers liable for misleading claims. Source: Drug Industry Daily