OR WAIT null SECS
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.
July 19, 2018
Inspectors found quality issues at bB BioChem Laboratories Inc, a California-based manufacturer of over-the-counter drug products.
New FDA guidance suggests ways to supplement labeling, to ensure that patients select and use nonprescription drugs safely.
FDA Commissioner, Scott Gottlieb, announced formation of a new, drug shortages task force and efforts to advance long-term solutions to prevent shortages.
July 16, 2018
Teva Pharmaceuticals, Major Pharmaceuticals, and Solco Healthcare are voluntarily recalling their products containing valsartan because of the presence of N-nitrosodimethylamine.
July 12, 2018
The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.
July 10, 2018
Certain blister card packages that do not meet US child-resistant packaging requirements are being recalled because they pose a risk of harm if the tablets are swallowed by children.
July 05, 2018
The agency is reviewing products containing valsartan supplied by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.
July 03, 2018
The agency published guidance on how the Generic Drug User Fee Amendments Reauthorization of 2017 applies to amendments to ANDAs and PASs.
July 02, 2018
The delivery device and drug form should be considered when choosing a test method for identifying and measuring particulates in inhaled drug products.
The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.