Day: February 7, 2019

FDA recently provided useful tips to developers of combination products that confirms well-understood processes while also providing more details to aid strategic development. Combination products offer an attractive option to provide a wholesome standalone product with convenient and reliable outcomes such a prefilled-syringes that offer ease for administration or patches filled with drugs that offer … Read more

FDA released its promised guidance on the least burdensome approach for medical devices this week which details the various options available to device developers for taking alternative approaches to regulatory submissions. FDA defined the least burdensome approach as “the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the … Read more