FDA releases new draft guidance on the information and data to be submitted for drug delivery devices and combination products
Titled "Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products", this draft "guidance addresses key aspects of drug delivery performance information for devices, and combination products that include device constituent parts, intended for delivery of a human drug, including a biological product." The introduction notes: "FDA is providing recommendations for development and organization of this information and these data to improve the consistency of this information in applications. Ultimately, these recommendations are intended to facilitate and streamline development of drug delivery devices."
As with all draft guidance, they are not enforced and comments will be accepted (in this case until 29Sep2024).
#fda #Device #DraftGuidance
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/essential-drug-delivery-outputs-devices-intended-deliver-drugs-and-biological-products?utm_medium=email&utm_source=govdelivery
------------------------------
Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
------------------------------
</bioanalysisandbiomarkers.blogspot.com>