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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.
November 21, 2019
The agency sent a warning letter to Torrent Pharma after an inspection found violations of current good manufacturing practices that included a failure to thoroughly investigate batch failures.
November 20, 2019
The guidance provides recommendations for the development and quality information that should be included in NDA and ANDA applications.
The approval of Givlaari (givosiran) is the first for treatment of acute hepatic porphyria, which results in the buildup of toxic porphyrin molecules during the production of heme.
The agency’s approval of Abrilada (adalimumab-afzb), a biosimilar to Humira, brings the total of approved biosimilars to 25.
November 15, 2019
Roche’s ADC, Kadcyla, has been recommended for approval in the EU for for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment.
November 14, 2019
The recent approval by FDA of Vumerity (diroximel fumarate), a new drug for treating multiple sclerosis, has a triggered a $150-million milestone payment from Biogen to Alkermes.
November 12, 2019
Developers of biosimilars have become dismayed with difficulties in gaining acceptance and reimbursement from the US healthcare system.
November 08, 2019
In a statement, Janet Woodcock MD, director of FDA’s Center for Drug Evaluation and Research, highlighted the agency’s efforts to enhance the efficiency of postmarket drug safety surveillance.
November 02, 2019
The author provides an overview of common residual moisture methods for lyophilized drug products and key points to consider during method selection and method development.
An effective quality control unit is independent from manufacturing and ensures current standards are followed.