US FDA issues norms on communication between IND sponsors, FDA during drug development

US FDA has issued draft norms on best practices for communication between IND sponsors and FDA during drug development. The clinical research industry is expected to provide its views on the subject by January end 2016. The key objective of this guidance is that FDA at critical junctures in drug development, could be able to facilitate earlier availability of safe and effective drugs. This guidance describes the need for timely interactive and appropriate interactions between the review team and the sponsor. It provides the types of advice appropriate for sponsors to seek from FDA in pursuing their drug development programme. FDA’s primary responsibilities with respect to INDs are, during all phases of an investigation, to ensure the safety and rights of subjects, and, during phase 2 and phase 3, to help ensure that the quality of the scientific evaluation of drugs is adequate to permit. Further, it believes that the timely review of IND submissions with appropriate feedback to sponsors can result in greater efficiency of the drug development process. It is of the view that the scientific and regulatory recommendations provided during drug development meetings with sponsors would result in more efficient and robust development programmes. However, this guidance does not apply to communications from industry trade organizations, consumer or patient advocacy organizations, other government agencies, not pursuing a development programme under an IND. The regulatory authority has stated that the norms suggested would ensure quality improvement process is dynamic. The IND phase of drug development is the time during which human trials of investigational drugs are conducted. From FDA’s perspective, the IND phase of drug development spans the time from the first IND-related submission which covers the pre-IND meeting request to the submission of a marketing application. The IND phase may also extend beyond initial approval or licensure to include additional trials relevant to the drug’s development and labeling. From the sponsor’s perspective, drug development is not limited to the IND phase because it also includes drug discovery and early work-up of compounds before IND submission and may include clinical trials conducted in other countries outside the US. Each year, sponsors and FDA engage in thousands of formal and informal communications, including meetings and teleconferences, during the IND phase of drug development. Because these communications are often opportunities to share information critical advice covering trial design, dose selection, nonclinical study requirements, manufacturing and facility issues. Therefore the regulator sees that it is vital to ensure that the interactions be conducted efficiently and consistently, with clear, concise, and timely communication. “Ideally, IND sponsors and FDA work collaboratively during the drug development process, having a shared public health goal of early availability of safe, effective, and high-quality drugs to the public. In this process, IND sponsors and FDA have distinct roles and primary areas of responsibility. Sponsors’ primary responsibilities are managing the overall development of their drug which covers supporting well-designed and well-conducted nonclinical and clinical trials for approval while ensuring patient safety, determining timing of regulatory submissions to the IND, said the regulator.