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PolarityTE (PTEIQ) to Release Quarterly Earnings on Friday

PolarityTE (PTEIQ) to Release Quarterly Earnings on Friday
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Critical Analysis: PolarityTE (NASDAQ:PTE) & Aziyo Biologics (NASDAQ:AZYO)

PolarityTE (NASDAQ:PTE – Get Free Report) and Aziyo Biologics (NASDAQ:AZYO – Get Free Report) are both small-cap medical companies, but which is the superior stock? We will contrast the two companies based on the strength of their analyst recommendations, profitability, valuation, risk, earnings, institutional ownership and dividends. Volatility and Risk PolarityTE has a beta of […]

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FDA Cracking Down on Unapproved HCT/Ps with Fourth Untitled Letter of 2023 | Sheppard Mullin Richter & Hampton LLP

On May 22, 2023, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) issued an untitled letter to AT Venture Center for Global.

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FDA Regulation of Human Cells and Tissues

Center for Biologics Evaluation and Research is on a roll in enforcing HCT/P regulations, this enforcement trend indicates that FDA is keeping a close eye on the promotion of such products and making sure they are properly classified and undergo appropriate premarket review.

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FDA New Untitled Letter to HCT/P Manufacturer

Center for Biologics Evaluation and Research CBER at Food and Drug Administration FDA published first untitled letter of the year to Thomas Advanced Medical LLC for marketing human cells, tissues, or cellular or tissue-based products HCT/Ps without FDA premarket review.

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