In the wake of the Department of Health and Human Services' (HHS) February announcement that they will be discontinuing the COVID-19 public health emergency (PHE) declaration on May 11, 2023.
Since the beginning of the COVID-19 pandemic, the US Food and Drug Administration (FDA or the Agency) has issued more than 80 guidance documents describing flexibilities that would be available.
Since the beginning of the COVID-19 pandemic, the US Food and Drug Administration (FDA or the Agency) has issued more than 80 guidance documents describing flexibilities that would be.
Bob Dylan sang, “Tell Me, I’ve Got to Know.” In January 2022, the Food and Drug Administration said the same to the medical device industry when it issued a draft guidance, “Notifying.
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Sunday, February 28, 2021, was Rare Disease Day. With so much
focus on COVID-19 throughout 2020, it s important to recognize
the continued work done in rare disease drug development by
sponsors and FDA throughout 2020. In addition, a number of policies
implemented in response to COVID-19 are expected to have a positive
impact on rare disease drug development going forward. Yet, the
lasting nature of these policies, post-pandemic, remains uncertain,
creating an opportunity for rare disease drug sponsors to be
proactive in engaging with regulatory authorities and the patient