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Hello,
I would like to have an advise from someone with the HC DEL experience.
In the Section 4.0 - Domestic FDF class product information, which Finished products have to be listed in this section? Are these supposed to be commercial FDFs or it should include FDF manufactured for clinical trails? Should it include FDF that are not yet approved?
We do manufacture FDF but non of them are yet approved. Few of our products are pending US approval, and few are manufactured for clinical trials in Canada and abroad. We are located in Canada, but we do not have products marketed in Canada except for clinical trail product.
Thank you