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Some of the FDA’s regulatory and compliance activities — including routine inspections — were placed on hold because of the partial government shutdown that began on Dec. 22 and continued into the new year. Read More
The FDA revised its recommendations on current good manufacturing practices for drug compounding outsourcing facilities, drawing a line between agency requirements for sterile and nonsterile drug products and outlining practices to protect against contamination. Read More
A Vermont initiative to allow importation of drugs from Canada could save millions of dollars each year, but it’s not clear that those savings would exceed the program’s costs, according to a report by the state’s Agency of Human Services (AHS). Read More
Civica Rx — the nonprofit drug company created by hospital groups to help deal with high generic drug prices and shortages — announced on Monday that it’s on track to launch more than 14 hospital-administered generic drugs this year and has added 12 new member groups representing 250 hospitals. Read More
The FDA will run out of funds for PDUFA reviews in “about one month,” FDA Commissioner Scott Gottlieb tweeted as the federal shutdown entered its third week. Read More
“We are pleased to have reached this settlement and will continue to defend our innovative medicines against any challenge,” said Neos CEO Jerry McLaughlin. Read More
A motion by a group of generic drugmakers for a gag order against the states suing them for price-fixing would be unwarranted and unconstitutional, the attorneys general said in a filing last week. Read More
The UK’s Medicines and Healthcare products Regulatory Agency released new details of how it plans to continue drug regulatory operations if there is no Brexit deal by March 29 — including new fees to cover its added regulatory burden. Read More