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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
The FDA is planning to modernize its recruitment and hiring practices to fill the several hundred vacancies plaguing the agency and attract more scientific talent. 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
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