by Katrina Rogers | Jan 14, 2020 | Medical Products, Medicine, Product Development
A Drug Master File, or DMF, is a submission to the FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. There are four types of DMFs: Type...
by Katrina Rogers | Jan 9, 2020 | Medical Products, Product Development
Codeveloped with Oncology Drugs The FDA released a procedural guidance in October 2019 which provides a streamlined process for submitting investigational in vitro devices (IVD) being codeveloped with investigational drugs in the same clinical protocol. The process...
by Katrina Rogers | Jan 7, 2020 | Uncategorized
In 2015, the FDA published a final order establishing that all Automated Electronic Defibrillators (AEDs) and their accessories require pre-market approval (PMA) based on the adverse event report and product recall history of these devices. AEDs without PMA will no...
by Katrina Rogers | Jan 2, 2020 | Uncategorized
As we learned in the eCTD series of posts, the implementation of the standard by the FDA includes a series of technical specifications which define the format of an application and its sections. The latest technical specification, Bioanalytical Methods Templates,...
by Katrina Rogers | Dec 24, 2019 | Uncategorized
I’ll take a brief break from posting new material on December 24th and 26th. Please browse some earlier posts and have a happy holiday!Reach out to me if you want to know more or discuss your medical product development...
Recent Comments