Regulatory Affairs

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One week after accusing Gilead Sciences of promoting an HIV drug off-label, an AIDS nonprofit is suing the company for allegedly “manipulating the patent system” to unnaturally extend the life of another medication. Read More

Drugmakers interested in establishing bioequivalence for their products have a treasure trove of data to dig through, as the FDA has just added 35 new product-specific guidances and updated 12 more. Read More

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

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

The House Oversight Committee has summoned former Turing CEO Martin Shkreli to testify before a Tuesday hearing on drug pricing. Read More