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It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.
March 13, 2019
Norman (Ned) Sharpless, director of the National Cancer Institute at the National Institutes of Health, will become FDA acting commissioner.
The FDA planned budget features added funds allotted to improved oversight of drugs, biologics, and medical devices.
FDA sent a warning letter to Jubilant Life Sciences after investigators found CGMP violations.
March 12, 2019
Ned Sharpless is tapped to take on acting commissioner role following Gottlieb’s resignation.
A federal court ordered Guardian Pharmacy Services to stop producing compounded drugs.
The agency prioritized the review of the generic angiotensin II receptor blocker to help relieve the shortage of valsartan due to recent recalls.
March 11, 2019
As part of FDA’s ongoing effort to modernize interactions with industry, FDA launched a portal to help with submissions of controlled correspondence via email instead of manual data entry.
March 08, 2019
The agency sent a warning letter to ANDAPharm, LLC after inspectors found the company’s cleaning and stability testing procedures were inadequate.
The new automated cloud-based tool allows for the design of targeted single-cell DNA custom panels.
FDA Commissioner Gottlieb released a statement on the agency’s efforts to refine the naming convention for biosimilars to balance competition and to help ensure patient safety.