Blog
Two Complimentary Regulatory Systems: 42 CFR Part 93 and 21 CFR Regulatory frameworks in life sciences are too often treated as separate conversations with research oversight on one side, product regulation on the other. A closer look at 42 CFR Part 93 and 21 CFR reveals something more important: a…
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On January 16, 2026, the FDA issued a warning letter to Boothwyn Pharmacy LLC, a compounding pharmacy in Kennett Square, Pennsylvania that produces semaglutide and tirzepatide injectables—the active ingredients in Ozempic®, Wegovy®, Mounjaro®, and Zepbound®. The letter followed an inspection from May to June 2025. This is not a story…
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A step-by-step guide to understanding, responding to, and resolving FDA inspection observations before they escalate. An FDA Form 483 is issued at the conclusion of a facility inspection when an investigator observes conditions that may constitute violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). It is not…
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In 2020, Lucira Health became the first company to receive FDA Emergency Use Authorization for a fully at-home molecular COVID-19 test. This was a breakthrough moment during the pandemic. By early 2021, Lucira went public. Revenue surged. The company reported periods of profitability rare for a young diagnostics firm. Then…
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The first session at the Dublin Library has successfully concluded, and it was an incredibly rewarding experience. What made it especially meaningful was the level of engagement with the audience. Attendees brought curiosity, insight, and a willingness to explore complex ideas together. Our discussion centered on infectious diseases, a field…
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The Molecular Diagnostics (MolDx)1 Program was developed by Palmetto GBA in 2011. This program has been implemented across 28 states to identify and establish coverage and reimbursement for molecular diagnostic tests. This was done as an effort to have uniform policies across four Medicare Administrative Contractors (MACs), namely Palmetto GBA,…
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Tuberculosis (TB) is a disease caused by a bacterium, Mycobacterium tuberculosis, that are spread from person to person through aerosols created when a person with disease of the lungs or throat coughs, sneezes, or speaks. When people nearby breathe in these bacterial aerosols, they may become infected. TB usually affects…
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A diverse community of trillions of commensal microorganisms reside in us, humans. Carefully molded communication between the commensal microbiota and our immune system controls tissue homeostasis. For e.g.: T-cells and B-cells have phenotypes and functions that are influenced by microbiota. These cells suppress responses to harmless antigens and enforce the…
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