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The road to grabbing the title of FDA commissioner keeps getting tougher for Robert Califf, with Sen. Bernie Sanders (I-Vt.) becoming the latest lawmaker to place a hold on his nomination. Read More
Batches of hastily assembled drug products distributed too soon and failure to document quality systems activities were among a host of GMP issues drugmakers violated, sometimes more than a year after the FDA first expressed concerns about companies’ repeated lapses during inspections. Read More
Beginning April 1, innovative drugmakers participating in the Medicaid rebate program can expect to see their returns shrink 8 percent, under a final rule from the Centers for Medicare & Medicaid Services. Read More
Calling for an immediate reform to the FDA’s opioid approval processes, Sen. Edward Markey (D-Mass.) announced he has placed a hold on the nomination of Robert Califf as the next commissioner of the agency. Read More
Shire is taking a second shot at the FDA for its eye treatment lifitegrast, resubmitting an NDA months after the agency said it needed more information before it could approve the candidate. Read More
Illegal conduct in the compounding and dietary supplement industries are two of the U.S. Department of Justice’s top three areas of increased focus, a deputy assistant attorney general said Dec. 9, 2015. Read More
The FDA has updated its list of scheduled guidances for the calendar year 2016, with a major focus on pharmaceutical quality, data integrity and generics. There are 102 planned guidances this year, compared with 92 last year. Read More
CDER Director Janet Woodcock sees PDUFA reauthorization and beefing up staffing as two top priorities that will occupy much of the FDA’s time over the next year. Read More
Roche says it is cooperating with inquiries from the Indian states of Gujarat and Telangana, where sales of its cancer drug Avastin were halted after 15 patients experienced pain and swelling in their eyes. Read More