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Description
Emphasis on mechanistic endpoints and histological markersnot medical use claims
Examples would include, but arent limited to, oligonucleotides, vaccines and monoclonal antibodies
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(a) In general.Section 1861(ee)(2)(D) of the Social Security Act (42 U.S.C
This proactive approach ensures that each patients plan remains optimized for their evolving needs, maximizing the therapys effectiveness
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