Very exciting times for PODAI have a feeling that the PODA system may be strongly embraced by drug manufacturers
as an inhalable therapeutic drug delivery system. From the recent press release...
As Chief Medical Officer, Dr. Gupta will be responsible for designing and implementing clinical trials designed to test the efficacy of Poda's smoking cessation products. In addition, Dr. Gupta will also help coordinate the development of additional products and treatment strategies across a wide range of inhalable therapeutic molecules, as well as coordinating and overseeing the application process for Poda's products to achieve certification as approved medical devices for smoking cessation or the inhalation of therapeutic molecules.
FDA regulations regarding "CGMP" CURRENT GOOD MANUFACTURING PROCESSES
The CGMPs require that equipment be of appropriate design to facilitate operations for its intended use and for cleaning and maintenance (see 21 CFR 211.63 and 211.67) and, that any equipment surface in contact with components, in-process materials, or drug products not be reactive, additive, or absorptive so as to "alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements" (see 21 CFR 211.65).