Inspectors at the US Food and Drug Administration (FDA) say lack of data integrity, transparency, record retention, and inadequate controls are some of the most common issues they see during ...
The FDA has flagged three third-party labs that submitted device testing data that may have falsified, invalid or copied from ...
Glenmark Pharmaceuticals' Goa facility received six procedural observations from the US FDA after a GMP inspection, with no ...
The U.S. Food and Drug Administration (FDA) recently announced a pilot program for "One-Day Inspectional Assessments," a new ...
Pharmaceutical Technology on MSN
US FDA rejects approval of Unicycive’s kidney disease therapy
The FDA did not raise concerns related to the clinical efficacy or safety data provided for OLC.
Foreign facilities failed FDA GMP inspections at up to 1.8x the U.S. rate. Journal of Pharmaceutical Innovation study quantifies a decade of oversight gaps. We first need rigorous, replicable ways to ...
The US Food and Drug Administration (FDA) will continue to focus on data integrity practices and take a hard look at OTC firms’ testing programs either through onsite inspections or using alternative ...
US FDA has flagged multiple deficiencies at Dabur India's manufacturing facility in Dadra and Nagar Haveli, including data integrity, contamination and maintenance concerns. Meanwhile, the Indian ...
Glenmark Pharmaceuticals has received a Form 483 with six observations following a US FDA GMP inspection of its Goa ...
The US FDA has issued Import Alert 66-40 for drugs manufactured at a part of Dabur India’s Silvassa facility after identifying deficiencies related to data integrity and maintenance during an ...
The U.S. Food and Drug Administration (FDA) recently announced the launch of a pilot program involving abbreviated, one-day inspectional assessments at manufacturing and other lower-risk facilities.
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