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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 23, 2018
The agency is sending a survey out to pharmaceutical companies in the UK to gain information on their preparedness for Brexit.
January 22, 2018
Non-essential activities and new regulatory submissions are on hold until a federal government funding agreement is reached.
January 19, 2018
Lonza Pharma & Biotech's's Modular Automated Sampling Technology (MAST) platform, which allows for the collection of up to 10 sterile sample sources for automated analysis in multiple analytical devices, won the CPhI Pharma Award 2017 for Excellence in Pharma: Bioprocessing.
January 17, 2018
The company has expanded its voluntary nationwide recall to include a second lot of Nexterone injection. This recall is due to particulate matter found in the product.
January 16, 2018
FDA is monitoring the IV fluid shortage occurring due to Hurricane Maria and is asking companies to submit data for the possibility of extending expiration dates.
The US Government Accountability Office released a report stating that FDA should make its plans to release guidance regarding nonbiological complex drugs public.
The agency has expanded the indication of AstraZeneca’s anti-cancer drug to include treatment for breast cancer with a certain inherited genetic mutation.
The two agencies have launched a program to develop safe and effective medical products to be used by American military personnel.
January 12, 2018
Labels must have special features to prevent tampering of pharmaceutical packaging.
January 11, 2018
The agency is requiring safety label changes to limit the use of prescription opioid cough and cold medicines in children younger than 18 years old.