FDA’s Authority Over Lab-Developed Tests Overturned: What the Court’s Decision Means for Lab Testing
Previously, this blog covered the FDA’s decision to regulate lab-developed tests (LDTs) as medical devices. However, ...
Ind., Oct. 14 sent a letter to Dr. Martin Makary, commissioner of the Food and Drug Administration, urging the agency to strengthen oversight of ...
The inspection machines market presents a broad pricing spectrum shaped by system complexity and application. Entry-level machines such as metal detectors and checkweighers, priced between USD 5,000 ...
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The FDA and FAO train manufacturers on quality food production
The Food and Drugs Authority (FDA) has organised training on Good Manufacturing Practices (GMP) for food manufacturing industries to promote high-quality food production. The three-day training, in ...
Novo Nordisk's Bloomington facility received an OAI label from the FDA due to compliance issues, including contamination by ...
MUMBAI, India, Oct. 13, 2025 (GLOBE NEWSWIRE) -- Lords Mark Industries Ltd., has received US FDA registration for its range of surgical consumables, orthopedic supports, and hygiene products — a ...
The U.S. federal government shut down Oct. 1, prompting furloughs at FDA, USDA and CDC, plus threats from the Trump ...
The U.S. Food and Drug Administration (FDA) on Tuesday issued a Complete Response Letter (CRL) for Scholar Rock’s (NASDAQ:SRRK) apitegromab Biologics License Application (BLA) for spinal muscular ...
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Aurobindo Pharma’s Apitoria Unit Completes US FDA Inspection with Procedural Observations
Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. The latest update is out from Aurobindo ...
The Able Laboratories fraud case exposed severe data integrity issues, emphasizing the need for robust quality control and management oversight in regulated laboratories. Despite extensive regulatory ...
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