The top observations identified in Form 483 reports from inspections conducted under the recently implemented Quality Management System Regulation (QMSR) include risk management, outsourcing and ...
The US Food and Drug Administration (FDA) has issued warning letters to several firms that have violated current good ...
The FDA has proposed excluding weight-loss drugs, such as Ozempic/Wegovy and Zepbound from a key compounding list, ...
The FDA's decision last year to make complete response letters public provides new insight into why therapies sometimes fail ...
Looking to clarify its expectations on manufacturer responses following inspections, the FDA earlier this year unveiled, for ...
The FDA plans to gather information from 250 compounding outsourcing pharmacies amid safety and quality concerns. In a May 1 notice, the agency said it will survey outsourcing facilities about ...
The FDA recently announced that it had identified “significant data integrity and study conduct concerns” in various bioequivalence studies conducted by the India-based contract research organization, ...
A specific lot of the widely prescribed anti-anxiety drug Xanax has been recalled nationwide for not passing quality control tests according to the Food and Drug Administration.
The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...
NBC 5 Responds has confirmed the Food and Drug Administration has paused a program used for testing quality of fluid milk and other dairy programs. An internal email seen by Reuters said this was due ...
Generic drugs account for more than 90 percent of prescriptions filled in the United States. Recent studies have found concering variability in quality and safety America’s generic drug supply, most ...
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