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These nanoparticles were self-assembled from a multifunctional peptide (antiPD-L1 sequence CVRARTR linked via a cathepsin Bcleavable linker to a DOX prodrug, FRRG) and DOX molecules

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Post-marketing surveillance of approved drugs involves millions of users over years, and often reveals rare side effects that clinical trials miss

We note that we are not proposing to change the July 1 deadline for technologies for which an application is submitted under the alternative pathway for certain antimicrobial products because they would continue to be eligible for conditional approval under 412.87(e)(3) (proposed to be redesignated as 412.87(f)(3)), as finalized in the FY 2021 IPPS/LTCH PPS final rule (85 FR 58740)