The agency cited quality issues at facilities testing Dexcom’s G6 and G7 monitors, including inadequate validation and risk ...
Ernst emphasized the strategic transformation of Tivic into a diversified therapeutics company, combining biologic and bioelectronic approaches to address immune dysregulation. This includes ...
While AI adoption in GMP settings is still evolving, regulatory agencies emphasize explainability and validation of AI models ...
DevOps and CSV form a powerful duo that, with strategic implementation, promises to propel the pharmaceutical industry.
We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...
The investment of over $6 million will expand LGM Pharma’s Rosenberg, Texas manufacturing facility as part of its Phase I ...
Leveraging Novoheart’s human-based drug discovery and validation platforms, Sardocor aims to expedite drug development and regulatory timelines for its gene and cell therapy pipeline.
New Delhi: Agreeing for Phase III clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to BDR ...
The Ravi Road Police made a significant breakthrough on Thursday by arresting a suspect involved in the manufacturing and distribution of ice, a highly dangerous and illegal drug, in Lahore.
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