Before initiation of a Phase-III clinical trial a prior FDA approval or permission is required ?
LW: All clinical trials in a development program are usually performed under the guidance of an IND (Investigational New Drug) application and all studies are listed in the IND, which is monitored by the FDA. This IND usually discloses the full development plans of the product. Additionally, Phase III trials are usually reviewed with the agency at an End of Phase II (EOP II) meeting and formal agreement is reached on safety and efficacy endpoints prior to study start. CHP: Before the initiation of ANY clinical trial, Regulatory approval / permission is required.
