To this end, FDA’s Project Protect encourages the submission of investigational new drug (IND) safety reports in a standard electronic format established by the International Council on Harmonization (ICH). OCE also aims to better assess safety reports from clinical trials through more effective tracking and review of safety information. Pazdur noted that FDA policies do not rule out such agreements and that the agency is willing to process a request from a physician, although sponsors are less likely to support such actions. 5 workshop is whether such early access should apply to unapproved indications of an approved cancer therapy. The agency’s Real-Time Oncology Review (RTOR) initiative aims to accelerate these activities further by enabling sponsors to grant FDA staffers access to certain clinical data prior to submission of an official application, as a way to address questions and issues in advance.Īs patient advocates continue to press for expanded access to investigational drugs, a tricky issue raised at the Feb.
Orbis clinical drug safety plus#
1 FDA approved 11 new molecular entities (NMEs) for oncology last year plus multiple supplemental indications, biosimilars, and medical devices. OCE marked its third anniversary in February with a public workshop to review ongoing projects and future plans, many of them described in OCE’s annual report for 2019. At the same time, FDA officials are working to ensure postapproval assessment of the safety and efficacy of new products that come to market based on limited clinical trials with few patients. Under the leadership of director Richard Pazdur, and benefitting from strong support from patient advocates andĬongressional policymakers, OCE is expanding pilot projects and international collaborations to further support access to new medicines. FDA’s Oncology Center of Excellence (OCE) continues to build on its successes in bringing innovative cancer therapies to patients through accelerated development and speedy approval of breakthrough treatments.
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