By the end of 2016, the FDA aims to increase pre- and post-market regulatory decisions using real-world evidence by 40 percent compared to 2015’s baseline. Next year, the goal expands to 100 percent.
For medical device manufacturers, that means a considerable shift away from relying mainly on clinical trials and instead focusing more on data from electronic health records, registries and medical billing claims.
While this switch in direction no doubt changes things for many device manufacturers, it shouldn’t come as much of a surprise. CDRH head Dr. Jeffrey Shuren has discussed the shortcomings of trial data in the past, pointing to the tendency for patients to comply with all instructions for use as a result of the constant monitoring that commonly happens during a clinical trial––conditions that aren’t the same in a commercial setting.Continue Reading
The FDA recently released the Center for Devices and Radiological Health’s (CDRH) Strategic Priorities guide highlighting the accomplishments they’ve made over the past two years, and more importantly, the main objectives for the years ahead.
We’ve pulled out the three key objectives for 2016 and 2017 from the 12-page paper and summarized them below.Continue Reading
This past December, the FDA released a draft guidance addressing a growing problem facing pharmaceuticals today: innovation.
Emerging technologies have made it possible for drug manufacturers to remedy a variety of problems that plagued operations in the past. Advanced automation equipment, for example, has led to less operator error while isolators and other separation technologies have lessened contamination on the processing line.
But as the FDA notes in the new draft guidance, the Agency’s inability to keep up with many of these emerging technologies has made pharmaceuticals hesitant to use them despite the obvious benefits.Continue Reading
The Form FDA 483 is a list of observations made by an FDA official during the closeout meeting of an inspection, all of which must be officially addressed one-by-one.
Although it’s not a final decision on your compliance status, if your organization is issued a 483, it should follow up by undergoing a Corrective Action Plan (CAP) to avoid possible disciplinary action by the FDA.
In almost all cases, the first step in a CAP is to craft a complete and thorough FDA 483 response. To help guide you through the process, we’ve compiled ten of the most important elements all 483 responses should include.Continue Reading