FDA Law Blog: Drug Discovery
JANUARY 4, 2023
As you may know, there are challenges related to developing potency assay(s), and the Alliance for Regenerative Medicine and the American Society of Gene and Cell Therapy recently published a white paper on a workshop held to discuss these challenges. The workshop is also discussed in Cell & Gene here and here.
The Pharma Data
MARCH 20, 2021
A schematic of domain and functional organization of two of the major structural proteins of SARS-CoV-2, Nucleocapsid protein as a target viral antigen for assay development. Based on our discovery experiments, we decided upon nucleocapsid protein as our target antigen for assay development.
Agency IQ
JULY 21, 2023
In parallel, FOCR developed a white paper that provided an overview of the potential regulatory applications for ctDNA in oncology. The paper, published in November 2021, primarily focused on the potential for ctDNA to serve as an early endpoint.
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