After over 3 years, the COVID-19 Public Health Emergency (PHE) will end on May 11, 2023, the Biden Administration announced last week.1After 3.5 years of the modified policy to allow for amore efficient path for COVID-19-related medical products to get to market, this begs the question of how it will impact the MedTech world.
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Innovations in Gendered Heart Disease Research
Heart disease is the leading cause of death in the United States equally impacting all. Being Women’s Health Week, we want to highlight the impact heart disease has on the livelihood of women and what new developments there are in the life sciences innovation world that would reduce the impact it has on society.
What is National Packaging Design Day
National Packaging Design Day is a special day for professional designers, a day to celebrate the art of packaging...
The Importance of Incoming Inspection
In regulated industries, the quality of the product is essential. Incoming inspections help monitor suppliers,...
Electronic Post Market Safety
The Food and Drug Administration (FDA) recently finalized the guidance for post-market safety reports of biologics and...
Magnesium and High Blood Pressure
The Food and Drug Administration (FDA) recently debuted a new eligible health claim for magnesium. In early January...
Initiation of Risk Assessments
Risk Assessments are a powerful tool used to elevate regulatory decisions and product changes. Risk assessments are...
Principles of Data Integrity
Data integrity is one of the most critical factors in any regulated industry. This is because any data error could...
Particulates in Final Product
Visual inspections ensure that visible particulates are not present in products manufactured by an organization....
RO Water System
In pharmaceutical manufacturing, there is the need to use sterile water in production and cleaning activities. This...
Over-the-Counter Products
Non-prescription drug products are classified as over-the-counter (OTC) drug products. OCT products are drugs that are...
Types of Combination Products
A combination product is a product composed of two or more regulated components. Examples of combination products...
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