Tag Archives: Compliance

Immunology and inflammation biotechnology company Alumis has recently entered the public markets, securing $250 million in pivotal funding to advance clinical trials of its leading drug candidate. The company aims to demonstrate the efficacy of its small molecule in treating plaque psoriasis, a competitive area currently targeted by several pharmaceutical giants. Alumis’ entry into Nasdaq […]

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AbbVie, a major pharmaceutical company already noted for its leadership in the inflammatory bowel disease (IBD) market with several blockbuster drugs, is further expanding its IBD offerings through strategic acquisitions and development of new drug candidates. Recently, AbbVie has reinforced its commitment to advancing IBD treatment by completing the acquisition of Celsius Therapeutics for $250 […]

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The U.S. Supreme Court has recently issued a series of significant decisions affecting various aspects of healthcare regulation and access. These decisions address the Chevron deference, access to the abortion pill mifepristone, and emergency abortion procedures in Idaho, reflecting the judiciary’s pivotal role in shaping healthcare policy. Chevron Deference Overturned A landmark decision by the […]

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In today’s BioPharmaceutical manufacturing landscape, the necessity for robust data integrity is paramount, as emphasized by the FDA’s Good Manufacturing Practices (GMP) regulations. These guidelines stress the need for precise and reliable data throughout supply chains, yet achieving this high standard can often be underestimated, especially when drug sponsors collaborate with manufacturing partners. Organizations must […]

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The ongoing fascination with emerging technologies and treatments in mental health care, particularly for conditions such Desert Storm Syndrome (DSS), has sparked a significant discussion about our priorities and the approach we take towards healing. The allure of novel therapies, such as MDMA-assisted treatment for PTSD, compels a deeper examination of whether our quest for […]

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Establishing a Quality Management System (QMS) is essential for medical device startups, not only for regulatory compliance but also for enhancing operational efficiency and product quality. In the U.S., QMS requirements for medical devices are specified under FDA 21 CFR Part 820, detailing necessary actions for developing and maintaining a compliant system. Globally, ISO 13485:2016 […]

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The Food and Drug Administration (FDA) has announced plans to broaden the scope of its Total Product Life Cycle (TAP) advisory program. Set to take effect in stages, the expansion will include radiological and ophthalmic medical devices starting from October this year, and orthopedic devices from January 1, 2025. The initiative aims to build upon […]

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Diabetes is a significant health concern in the United States, affecting approximately 15% of the adult population and resulting in over 100,000 deaths annually. Given the serious and pervasive nature of this condition, the development and evolution of medical devices aimed at diabetes management are increasingly critical. These devices, particularly continuous glucose monitors (CGMs), are […]

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The U.S. Food and Drug Administration (FDA) has intensified its scrutiny over the imports of plastic syringes from China due to concerns over their quality. Specifically, during November, the FDA highlighted issues potentially affecting these syringes, including the risk of leaks and breakages. Consequently, the agency advised healthcare providers to opt for syringes produced outside […]

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Unfortunately, the text you’ve provided seems to be an introduction or a fragment and it doesn’t contain enough content to summarize into 800 words. The paragraph offers a brief overview of the FDA’s new draft guidance on diversity action plans, indicating that this guidance was completely rewritten following new authority granted to the FDA by […]

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