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The FDA retains full discretion to accept, modify, or reject the recommendation, and formal inclusion on the 503A Bulks List requires a separate FDA rulemaking process with no announced timeline - legal analysts covering the vote have noted that a final rule could realistically take many months to over a year to materialize

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The An 2019 clinical trial in Annals of Dermatology tested a crosslinked hyaluronic acid microneedle patch loaded with sh-Oligopeptide-1 and Acetyl Hexapeptide-8 against vehicle control in Korean women with peri-orbital wrinkles, and found significant reductions in wrinkle depth and improvements in skin elasticity over 8 weeks [37]

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