The US FDA Initiates its First Step Towards Project Orbis for Concurrent Review of Cancer Therapies

 The US FDA Initiates its First Step Towards Project Orbis for Concurrent Review of Cancer Therapies

The US FDA Initiates its First Step Towards Project Orbis for Concurrent Review of Cancer Therapies

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


Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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