The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
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
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
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