Drug Delivery Devices: Approaches and Manufacturing

A new class of drug delivery device which can inject doses far larger than today’s syringes or auto injectors has developed i.e., Bolus Injectors having the capability to deliver more than 1 ml of a drug subcutaneously in a simple, reliable, and inexpensive manner. In the last 12 years, drugs have been delivered using self-regulated and Nano-technology systems. The manufacturers need to consider clinical guidelines and regulatory requirements governing combination products also differ from both pharmaceuticals and medical devices. To change that perception, the FDA last year announced $40 million to a new Medical Device Innovation Consortium (MDIC) charged with simplifying the process of designing and testing new technologies. With input from industry, government, and other nonprofit organizations, public-private MDIC will prioritize the regulatory science needs of the medical device community and fund projects to streamline the process.

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