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The FDA published new product-specific draft guidances for establishing bioequivalence in 20 drugs and combinations. The agency also revised draft guidances for 12 more substances. Read More
FDA Commissioner Scott Gottlieb updated lawmakers on the agency’s plan to help lower drug prices using its “untapped authority” to increase competition and streamline generic drug approvals. Read More
The House passed its version of the FDA user fee reauthorization package, which is expected to bring in $1.42 billion in fiscal 2018, by a voice vote. Read More
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