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FDA lays groundwork for variant-focused vaccines

FDA lays groundwork for variant-focused vaccines Presented by Pharmaceutical Care Management Association With help from Emily Martin, Brianna Ehley On Tap and urges manufacturers to study options. Today: House hearing on Covid vaccines plus a big J&J production pledge. This week: HHS nominees at that Senate potentially clearing the way for an FDA pick. A message from Pharmaceutical Care Management Association: The Biden Administration postponed the effective date for the Medicare rebate rule until 2023. Despite the delay, uncertainty remains. The cleanest path forward to avoid disruption to Part D, caused by jarring monthly premium increases, is for Congress to quickly repeal the rebate rule outright.

FDA Warns of Potential Pulse Oximeter Inaccuracies

FDA Warns of Potential Pulse Oximeter Inaccuracies Feb. 22, 2021 Pulse oximeters, which measure blood oxygen levels, have become popular during the COVID-19 pandemic for people to track their oxygen saturation, but they may not always be accurate, the FDA cautioned in new guidance released Friday. Several factors can affect the accuracy of pulse oximeters, including poor circulation, skin temperature, skin thickness, current tobacco use, use of fingernail polish, and dark skin pigmentation, the FDA said. Recent reports have found that Black patients may not receive accurate readings from some oximeters. “While pulse oximeters may be useful for estimating blood oxygen levels, these devices have limitations that can result in inaccurate readings,” William Maisel, MD, director of the FDA’s Office of Product Evaluation and Quality, said in a statement.

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