Q: I administered an HCT/P that requires but lacks premarket approval to a patient with a good response prior to May 31, 2021. Can I continue to administer this product to this same patient(s)? A: No, a product that requires but lacks premarket approval may not be lawfully marketed. Y...
In the future, the R&D of new molecular entities may combine advanced delivery technologies to make drug candidates into more therapeutically effective formulations. Keywords: drug delivery system; FDA-approval drugs; generic drugs; oral sustained-release preparation; inhalation; complex injection; ...