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However, the largest group of Ab-mediated autoimmune diseases are driven by IgG [9]

Comment: With respect to the newness criterion at 419.66(b)(1), the applicant reiterated that the VersaVue TM Single-Use Flexible Cystoscope received 510(k) clearance from FDA on October 6, 2023, and that it submitted an application for pass-through status on February 11, 2025, which is within 3 years of the initial market authorization

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A Phase I pharmacokinetic and biological correlative study of oblimersen sodium (genasense, g3139), an antisense oligonucleotide to the bcl-2 mRNA, and of docetaxel in patients with hormone-refractory prostate cancer