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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.
January 14, 2020
Top of CDER’s to-do list for 2020 is tracking adverse events more effectively and combating the opioid crisis.
January 09, 2020
The company has various projects and launches scheduled for 2020 as part of its anniversary celebration.
January 03, 2020
The numbers of new molecular entities approved in 2019 are close to or exceed FDA’s performance in most previous years.
The agency sent a warning letter to Henan Kangdi Medical Devices Co. Ltd after an inspection found CGMP violations that included a variety of failures of the company’s quality unit.
January 02, 2020
Pressures on FDA will affect industry’s success in bringing new therapies to market.
FDA sent a warning letter to GPT Pharmaceuticals Pvt. Ltd. after inspectors found CGMP violations that included equipment that was not properly maintained.
Aurobindo Pharma USA, Inc. voluntarily recalled Mirtazapine Tablets due to an error on the label that listed the incorrect strength.
FDA’s approval rate slowed, but the US agency is still ahead of its international counterparts in green-lighting new drugs for market.
Focusing on symptoms instead of root causes locks teams into a corrective, rather than preventive, mindset.
Past mistakes and misstatements have adversely influenced industry decontamination practices with vapor phase hydrogen peroxide, and this article endeavors to clarify the process.