RE:RE:New Press Release - Theratechnologies Receives January 2024 PDUFA Goal Date for Tesamorelin F8 Formulation sBLAThe pen injector is classified as a medical device which has to be approved separately. There are various classes of medical devices depending on the nature of the device, I believe the pen injector would be classed in the second category as it is used to penetrate the body! Some other medical devices are categorized at higher classes due to more complex uses. The higher classes the more complex approval process!!
Lee430 wrote: Question, will the FDA aproval of F8 formula also include the Pen delivery system or is that a seperate aproval process?