Nanotech Working Group Is Getting Down To The Fine Details Of Defining It
Executive Summary
An international scientific working group is trying to describe the defining characteristics of nanotechnology drugs to help support regulatory development in this nascent field
You may also be interested in...
FDA Ramps Up Data Gathering On How To Regulate Nanotech In Drugs, Biologics
By 2015, some predict, nanotechnology will play a critical role in up to 60% of biopharma products.
Genzyme Receives Complete Response, Warning Letters For Lumizyme
The hits just keep on coming for Genzyme. On a March 2 call with investors, the firm had to announce not just a "complete response" letter for its 2000-liter scale-up of Myozyme (which will be called Lumizyme for the larger production scale), but also that its Allston Landing manufacturing site had received a 483 report from FDA and a subsequent warning letter
Genzyme Receives Complete Response, Warning Letters For Lumizyme
Despite receiving a “complete response” letter and manufacturing warning letter on the same day, Genzyme remains upbeat about the likelihood of approval for its 2,000L scale-up of Myozyme.