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.
U.S. lawmakers Wednesday introduced a bill that would prohibit patent litigation settlements in which a brand drugmaker compensates a generic drugmaker to delay sales of a competing generic drug, commonly referred to as “pay-for-delay” deals. Read More
The House late Thursday passed a comprehensive budget deal that, in easing some of the pain of sequestration, puts the FDA’s fiscal 2014 outlook in the hands of congressional appropriators typically friendly to the agency. Read More
The FDA is not backing down on its stance that Novartis abused the citizen petition process to stall approval of generic versions of Reclast, and the agency has rejected a company request that it retract its statements from the public record. Read More
A bipartisan federal budget deal reached Dec. 10 removes the threat of sequestration hanging over fiscal 2014 and 2015 FDA user fees, and would ensure they aren’t locked away along with some of last year’s payments. Read More
A group of generic drugmakers is proposing the FDA take the lead on initiating drug labeling changes prompted by adverse events, rather than relying on individual companies to initiate the changes. Read More
CDER Director Janet Woodcock told lawmakers the FDA’s current medical information system is outmoded and the agency is developing the Patient Medication Information (PMI) document — a single, standardized medication information leaflet — to fix it. Read More