Search Results for keywords:"FDA recommendations"

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Search Results: keywords:"FDA recommendations"

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  • 2024-30776 — Modifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence
    Type:Notice
    Citation:89 FR 105613
    Reading Time:about 22 minutes

    The Food and Drug Administration (FDA) is recommending changes to how buprenorphine-containing products for opioid dependence are labeled. Currently, labels might be misunderstood as having maximum dosage limits, such as 16 mg or 24 mg per day, which isn't the case. These changes aim to clarify that higher doses can be prescribed if needed. Additionally, the FDA suggests adjusting labels to show that pregnant patients may require increased doses to ensure effective treatment.

    Simple Explanation

    The FDA wants to change the labels on some medicine that helps people with opioid problems because the current labels might make doctors think there's a strict limit on how much can be given, even though they can give more if needed, especially to pregnant women.

  • 2021-03421 — Guidance Documents Related to Coronavirus Disease 2019; Availability
    Type:Notice
    Citation:86 FR 10285
    Reading Time:about 8 minutes

    The Food and Drug Administration (FDA) announced the availability of guidance documents related to the COVID-19 public health emergency. These documents were released quickly due to the urgency of the pandemic and are open for public comments in line with the FDA's good guidance practices. The guidance is accessible online and serves as the FDA's current recommendations, but they are not binding. Public health determinations and a national emergency declaration underpin this accelerated release.

    Simple Explanation

    The FDA has made some special rules to help with COVID-19, and they want people to know about them and give their thoughts. These rules are their best advice, but you don’t have to follow them exactly if you have a better idea.