Newsletter - February 7, 2019
FDA Explains How to Do Less to Get More: Least Burdensome Approach
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....Read More
FDA’s Combination Product Guidance Clarifies Common Questions
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....Read More
FDA Explains How to Do Less to Get More: Least Burdensome Approach
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....Read More
FDA’s Combination Product Guidance Clarifies Common Questions
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....Read More
