You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
Both companies and the FDA continue to be frustrated with the mismatches between drug and device
regulations along with the communication challenges between the product centers that lead to inefficiencies. FDA officials are signaling that the combination products review process is ready for reform and the 2017 user fee authorizations offer a good opportunity to make much needed changes.
Topics: Jeffrey Shuren, Combination Products, FDA, Robert Califf
On February 5th, the CDRH released its strategic priorities for 2014 and 2015. This is the first time the device center has released a two-year strategic plan rather than an annual plan. The center is focusing on strengthening the clinical trial enterprise, striking the right balance between pre-market and post-market data collection, and providing excellent customer service.
Topics: Center for Devices and Radiological Health, Strategic Priorities, Jeffrey Shuren