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At a meeting on opioids abuse, FDA Commissioner Scott Gottlieb announced that the agency will expand its REMS requirements for extended-release and long-acting opioids to the manufacturers of immediate-release formulations — which account for 90 percent of the opioid painkiller prescriptions written each year in the U.S. Read More
The Senate and House appropriations committees approved their respective bills that provide a total of $5.2 billion for the FDA in fiscal 2018, $491 million more than the current fiscal year. Read More
With just over two months left in the program, the FDA finalized a question-and-answer guidance for GDUFA I, covering ANDA reviews, inspections and self-identification of facilities. Read More
FDA Commissioner Scott Gottlieb expanded on his drug competition action plan at a day-long agency meeting on generic competition. To make the process more transparent, the agency is considering publicizing when it grants permission for brand-name companies to sell product samples of REMS-covered drugs to developers of generics. Read More
Companies should not claim that child-resistant packaging is “child-proof,” as the standards for child-resistant packaging are not designed to eliminate the risk of accidental ingestion completely. Read More
A California company violated federal law by making and selling as a dietary supplement a product containing prescription drugs used to treat erectile dysfunction, the FDA said. Read More
The U.S. District Court for the Eastern District of Tennessee entered a permanent injunction against Crown Laboratories of Johnson City and its CEO, Jeffrey Bedard, after accusations of distributing unapproved and misbranded drugs. Read More
AbbVie filed a federal lawsuit in Delaware claiming Boehringer Ingelheim is illegally infringing on patents in its development of a Humira biosimilar. Read More
An FDA advisory committee voted 10-to-1 Thursday to recommend approval of Pfizer’s Xeljanz (tofacitinib) for treatment of psoriatic arthritis. Read More
As one of its last items of business before leaving town for the summer, the Senate overwhelmingly voted to reauthorize the FDA’s user fee agreements through fiscal 2022, completing over two years of work and negotiations with private industry. Read More