Quality Systems

Apr 06, 2018
By Pharmaceutical Technology Editors
The contract manufacturing organization’s facility in Boulder, CO, has passed general inspection from FDA.
Apr 05, 2018
By Pharmaceutical Technology Editors
The agency’s plan outlines its approach to implementing medical product programs and the use of financial resources.
Apr 05, 2018
By Pharmaceutical Technology Editors
The European approval marks the first approval for a biosimilar in that region resulting from the companies’ joint portfolio.
Apr 04, 2018
By Pharmaceutical Technology Editors
A new book published in response to new USP chapters and ICH Q3D guidelines on measuring elemental impurities provides a practical guide for using plasma spectrochemistry for pharmaceutical analysis.
Apr 03, 2018
By Pharmaceutical Technology Editors
The agency has accepted AstraZeneca’s biologics license application for an investigational leukemia drug candidate and granted it priority review.
Apr 03, 2018
By Pharmaceutical Technology Editors
The agency has release a report providing an overview of steps taken to enhance benefit-risk assessment in the review of drugs.
Apr 03, 2018
By Pharmaceutical Technology Editors
The company is recalling Pasta De Lassar Andromaco zinc oxide diaper rash treatment after FDA analysis confirmed the product contained high levels of yeast, mold, and bacteria.
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