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January 4, 2024
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and...
April 3, 2023
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...
March 28, 2023
On March 10, 2023, the U.S. Food and Drug Administration (FDA) issued a Notice summarizing which of the agencyโs COVID-19-related guidance documents will be rescinded and which will be...
March 23, 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...
March 21, 2023
On March 13, 2023, FDA issued a notice regarding guidance documents related to the COVID-19 pandemic, including which of the guidance documents willโฆ
March 17, 2023
The COVID-19 pandemic presented the U.S. Food and Drug Administration (FDA or Agency) with a monumental task of shifting its operations and the way it approached the regulation of...
March 16, 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...
February 27, 2023
Falls Church, VA (PRWEB) February 27, 2023 -- Grace McNally, senior vice president of regulatory compliance at Greenleaf Health, and a 33-year veteran of the
August 16, 2022
The U.S. Food and Drug Administration (FDA) recently issued draft guidance on how it will continue to conduct remote regulatory assessments (RRAs) after the COVID-19 public health...
November 2, 2021
Key Takeaways - The COVID-19 pandemic led the U.S. Food and Drug Administration (FDA) to pause most foreign and domestic inspections and begin conducting remote interactive...