Shots:

• The US FDA announces Project Orbis- an initiative of the FDA Oncology Center of Excellence (OCE) providing a framework concurrent submission and review of oncology therapies in collaboration with TGA and Health Canada- allowing for simultaneous decisions in all three countries
• The collaboration allows cancer patients to receive earlier access to products in other countries- where there is a delay in regulatory submissions- regardless of its FDA approval. Under the Project Orbis- in conjunction with decisions by TGA and Health Canada- the FDA granted accelerated approval to Lenvima + Keytruda for certain types of advanced endometrial carcinoma
• Project Orbis is an initiative of the FDA Oncology Center of Excellence (OCE) involving the Australian Therapeutic Goods Administration and Health Canada. The FDA’s OHOP holds a monthly teleconference with TGA- HC- EMA- PMDA and Swiss medic for exchanging information about the applications under review

Click here- Project Orbis to­ read full press release/ article | Ref: FDA | Image: FDA