Blue book memorandum g95-1 fdating
All of these are questions of materials characterisation and chemistry. Application of thought and expertise is required to determine the most appropriate course of action. In summary both bad economics and bad science. This is a quantum leap from the old G Blue Book Memo.
Well, understand the materials of the device. For the treatment of human diseases, nasal and pulmonary routes of drug delivery are gaining increasing importance. They do not necessarily require that testing be conducted.