The query should include topline efficacy and safety results that would support the application, as well as a global submission plan (GSP) that includes company points of contact and names/contacts of global affiliates. Criteria for consideration includes: high impact, clinically significant applications, should generally qualify for priority review because of improvement in safety/efficacy. Q: How does a sponsor make a Project Orbis request and what are the criteria?Ī: Sponsors can inquire from the respective Office of Oncologic Diseases review divisions whether their proposed application submission would be suitable for Project Orbis.

Sponsors can request Project Orbis for their applications. Q: How does an application get nominated for Project Orbis?Ī: The FDA review team can recommend an application for Project Orbis based on a combination of the following: breakthrough designation, impressive results, and unmet need. Q: Will other therapeutic areas be involved in future Project Orbis reviews?Ī: Other therapeutic areas are not within the Oncology Center of Excellence’s purview. FDA is exploring other options to collaboratively work with regulators interested in this collaborative review program. Q: Will other countries be involved in future Project Orbis reviews?Ī: At this time, we are unable to increase the number of countries participating in Project Orbis. Does Canada and Australia have similar expedited approval programs?Ī: Yes, Health Canada approved the 1st Project Orbis application under conditional approval with conditions and TGA used its provisional approval with conditions of registration. In Canada, the approved indication was slightly different than the approved indication in the United States and Australia. The regulators exchanged drug labels to learn about any potential differences. Each country has its own format for the drug label. Q: Did the three countries issue the same drug labels for the two products involved?Ī: No. The aim of this collaborative review was to identify any regulatory divergence across the review teams. Q: For the first Project Orbis review, what was the role of each country in the review process?Ī: The three regulatory agencies collaboratively reviewed this application, allowing for simultaneous decisions in all three countries. Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA) and Health Canada (HC) took part in this application review. “Over the past year, this plant has excelled in several key areas and made significant process improvements to help meet our customers’ needs faster and more efficiently.Q: Which countries were involved in the first Project Orbis collaborative review ?Ī: The U.S. “We were very pleased to present this award to the Rexdale team,” said Orbis vice president of operation Pat Feeney. Steve Smith, plant manager was presented the award by Orbis president Bill Ash, with Toronto Mayor Rob Ford, and Ward 1 Councilor, Vincent Crisanti also in attendance. The Rexdale plant, manufacturing home of the company’s Orbis Green Bin for organic waste collection and a wide variety of other reusable products, was selected because of “significant improvements in on-time delivery to its customers, employee retention, increased profitability, environmental upgrades that reduced overall water usage and a very strong employee safety score, while increasing its annual shipments by nearly 20 per cent,” according to an Orbis news release.

Orbis Corporation, a manufacturer of sustainable reusable plastic packaging, has named its Rexdale, Ontario facility as its plant of the year.

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