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FDA Provides Guidance to Industry for Detecting and Preventing Nitrosamines in Drugs
… … Since the outset of our discovery of impurities called nitrosamines in some types of drugs more … While nitrosamines are common in water and foods, nitrosamine impurities may increase the risk of cancer if … impurities, today we’re publishing our guidance Control of Nitrosamine Impurities in Human Drugs for …
FDA Statement on the FDA’s ongoing investigation into valsartan and ARB class impurities and the agency’s steps to address the root causes of the safety issues
… tatement-fdas-ongoing-investigation-valsartan-and-arb-class-impurities-and-agencys-steps … Last summer, the FDA learned … angiotensin II receptor blocker (ARB) medicines contain nitrosamine impurities that don’t meet the agency’s safety … several manufacturing violations, including impurity control, change control and cross contamination from one …
FDA Alerts Patients and Health Care Professionals to Nitrosamine Impurity Findings in Certain Metformin Extended-Release Products
… uncements/fda-alerts-patients-and-health-care-professionals-nitrosamine-impurity-findings-certain-metformin … Español The … (ER) formulation of metformin, a prescription drug used to control high blood sugar in patients with type 2 diabetes. … understand that patients may have concerns about possible impurities in their medicines, and want to assure the public …
Statement from Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on impurities found in diabetes drugs outside the U.S.
… odcock-md-director-fdas-center-drug-evaluation-and-research-impurities-found … Español The U.S. Food and Drug … professionals. Metformin is a prescription drug used to control high blood sugar in patients with type 2 diabetes. … FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the …
FDA Newsroom: Q&A on angiotensin II receptor blocker (ARB) medication class investigation
… from the public about the ongoing investigation into the nitrosamine impurities found in the ARB class of medicines, particularly … actions. The 2017 inspection uncovered some quality control issues, including a failure to adequately investigate …
FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications
… an ongoing FDA investigation into probable cancer-causing impurities in certain commonly prescribed heart medicines. … violations at ZHP’s Chuannan facility, including impurity control, change control and cross contamination from one … issues cited in the warning letter are associated with the nitrosamine impurities found in these drugs, and these …
Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications
… ARB medicines, and we are concerned about the presence of nitrosamine impurities in these drugs. Millions of people benefit from … the warning letter cites Lantech’s failure to control and monitor procedures to recover solvents to ensure …
Parenteral Drug Association/Food and Drug Administration Joint Conference – The Future is Now: Effective Quality Management and Robust Manufacturing - 09/14/2020 - 09/16/2020
… will also learn about hot topics such as supplier quality control, new large volume parenteral technical approaches, … tools to help strengthen deviation management, preventing nitrosamine impurities, and how regulators assess firms in times of …