b'Hiringexperiencedregulatoryexpertsorpartneringwithan organizationwithexistingexpertiseinnavigatingthischallenging process can help ensure that you submit a successful application and meet your timelines. In the U.S., engaging a CRO (such as Altasciences) thatalreadyhasScheduleIlicensingcansavetimeandensurea smoother process.Commercialization Gettingyourdrugtocommercializationcanposeanadditional challenge.Developingin-housecompetenciesorpartneringwitha CRO with the experience and expertise to conduct the appropriate studiesdriving tests, human abuse potential, drug-drug interactions, cardiactesting,amongothersiscrucial. Giventhepotentialfor after-effects, additional provisions need to be made for longer-term assessment and monitoring. In addition, it is important to ensure that data from well-controlled, well-designed trials is generated to support the regulatory package. This increases the likelihood that your drug will be approved and enables you to make the appropriate labelling claims to differentiate your drug from others on the market.The Future of Psychedelic Therapeutic Development Theregulatorylandscapeispoisedtoevolveasevidenceforthe therapeutic potential of psychedelics continues to accumulate, thus requiringtheneedtoremovethemfromScheduleIclassification, which is solely for drugs without approved medical use. In addition, schedules are typically based on a drugs medical utility and potential forabuse.IntheU.S.,eightfactorsareconsideredforscheduling drugs 3 :1.The drugs actual or relative5.The scope, duration, and potential for abuse significance of abuse2.Scientific evidence of the drugs6.What, if any, risk there is to the pharmacological effects public health3.The state of current scientific7.Its psychic or physiological knowledge regarding the drugdependence liabilityor substance 8.Whether the substance is 4.Its history and current patternan immediate precursor of a of abuse substance already controlled'