by Soller RW, Shaheen C
Soller RW, Shaheen C. The Switch Considerations List: ‘Considerations for Rx-to-OTC Switch’ Refined by a Critical Synthesis of FDA Comments on Expanded Access for Naloxone. SelfCare 2012;3(6):121-137
The Food and Drug Administration (FDA) recently held a meeting to explore new paradigms for drug availability under the regulatory rubric of novel conditions of nonprescription drug use. Subsequent to this meeting, FDA held a workshop on naloxone for prevention of death from opioid overdose. This represented the first publicly discussed switch candidate for novel conditions of nonprescription drug use.