(Total Views: 861)
Posted On: 02/22/2021 12:50:51 PM
Post# of 148908
MUST READ......MUST READ....
FDA's "Guide For The Industry".... (Date February 2021 not day)
Development of Monoclonal Antibody Products Targeting SARSCoV-2,
(The FDA is adapting/changing....Improving? Loosening up criteria finally?
(might explain what's going on right now and why the delay.....)
Might this indicate they may approve drugs that don't meet Primary Endpoint?
Our EUA may involve a combo cocktail with ???
EUA forced Combo with remdesivir would be classic!!!!
https://www.fda.gov/media/146173/download
Sponsors of monoclonal antibody products targeting SARS-CoV-2 should consider the following guiding principles:
• Given the serious concerns raised by the emergence of SARS-CoV-2 variants, FDA intends to leverage its emergency authorities under section 564 of the FD&C Act, when appropriate, to foster the development and availability of therapeutics for use during the current public health emergency. When scientifically supported, FDA will streamline the data necessary to support the development of monoclonal antibody products targeting SARS-CoV-2 and also expedite the review of these data.
• Given the dynamic public health situation created by changes in the prevalence of new variants over time, FDA’s streamlined approach will depend on its current assessment of benefit and risk for the intended use and population, the monoclonal antibody’s expected coverage of important emerging variants, as well as FDA’s then-current understanding
of SARS-CoV-2.
• FDA strongly recommends that individual monoclonal antibody products be developed with the expectation that they will be combined with one or more monoclonal antibody products that bind to different epitopes5 to minimize the risk of losing activity against emergent variants. FDA encourages collaborations between sponsors of individual monoclonal antibody products to address this unmet medical need.
FDA's "Guide For The Industry".... (Date February 2021 not day)
Development of Monoclonal Antibody Products Targeting SARSCoV-2,
(The FDA is adapting/changing....Improving? Loosening up criteria finally?
(might explain what's going on right now and why the delay.....)
Might this indicate they may approve drugs that don't meet Primary Endpoint?
Our EUA may involve a combo cocktail with ???
EUA forced Combo with remdesivir would be classic!!!!
https://www.fda.gov/media/146173/download
Sponsors of monoclonal antibody products targeting SARS-CoV-2 should consider the following guiding principles:
• Given the serious concerns raised by the emergence of SARS-CoV-2 variants, FDA intends to leverage its emergency authorities under section 564 of the FD&C Act, when appropriate, to foster the development and availability of therapeutics for use during the current public health emergency. When scientifically supported, FDA will streamline the data necessary to support the development of monoclonal antibody products targeting SARS-CoV-2 and also expedite the review of these data.
• Given the dynamic public health situation created by changes in the prevalence of new variants over time, FDA’s streamlined approach will depend on its current assessment of benefit and risk for the intended use and population, the monoclonal antibody’s expected coverage of important emerging variants, as well as FDA’s then-current understanding
of SARS-CoV-2.
• FDA strongly recommends that individual monoclonal antibody products be developed with the expectation that they will be combined with one or more monoclonal antibody products that bind to different epitopes5 to minimize the risk of losing activity against emergent variants. FDA encourages collaborations between sponsors of individual monoclonal antibody products to address this unmet medical need.
(6)
(1)Scroll down for more posts ▼
