Competent Authorities for Medical Devices (CAMD)-an association representing national medical device licensing agencies, many of whom also approve medicines-has given a “low” priority to guidance for combination products on the “appropriate level of interaction with relevant authorities” (4). Industr...
Discussions between industry and EMA on the finalization of the MDR guideline are likely to centre on how much current quality principles and processes used by DDC manufacturers need to be changed to deal with the likely longer-term growth in DDC products. References 1. EMA, Draft Guidance 2591...
Companies entering the US market need to bear in mind new guidance from the FDA. New draft guidance documents covering Essential Drug Delivery Outputs and Use Related Risk Analysis were published in June and July 2024 respectively, with the industry given 60 days to submit comments. ...
Experts from industry and the U.S. Food and Drug Administration (FDA) recently joined forces to take a closer look at the interface of medical device and drug development, called combination products. Their new technical information report, AAMI TIR105:2020: Risk management guidance for combination...
For combination products, approval is based upon the primary mode of action. FDA agencies write guidance statements for industry. Drugs are approved via a ne...John W
According to Perfuze, the Millipede 088 device, which initially received FDA clearance in 2022, facilitates the safe insertion and guidance of microcatheters for neurointerventional or diagnostic procedures. It first received European CE Mark approval in 2021. ...
combination products in a compliant manner, 21 CFR Part 4 on combination products was introduced early in 2013. Later, in 2015, the FDA issued draft guidance onCurrent Good Manufacturing Practice Requirements for Combination Products, which was subsequently finalized in 2017 to help further ...
US Food Drug Adm. 2021. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/classification-products-drugs-and-devices-and-additional-product-classification-issues. Accessed 1 Jul 2021. Download references Funding This research was supported by a Grant (21153MFDS431) from the ...
FDA. Guidance for industry: integration of dose-counting mechanisms into MDI drug products. 2003. Conner JB, Buck PO. Improving asthma management: the case for mandatory inclusion of dose counters on all rescue bronchodilators. J Asthma. 2013;50(6):658–63. doi:10.3109/02770903.2013.789056. ...