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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
The FDA approved the most generic drugs during May and June since it began tallying approvals, according to the agency’s latest report on the generics program — helping Commissioner Scott Gottlieb make good on his early promises to speed generics to market in an effort to lower U.S. drug prices. Read More
The Association for Accessible Medicines filed a lawsuit against the attorney general of Maryland, hoping to block the state’s recently passed law ostensibly banning generic drug price gouging. 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