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Better Human Factors Analysis is Driving New Combination Product Technologies Designed to Reduce User Errors

Multi-sensory training tools and design features for auto-injectors, including audio instructions, are among the error-reduction technologies being driven by better human factors (HF) analysis in the drug/device combination product arena....

EU Biological Product GMPs Will Expand in Breadth and Depth With New Annex 2

The soon-to-be finalized overhaul of EU GMP Annex 2 will significantly expand the breadth and depth of its coverage of the manufacture of biological products and will bring advanced therapy medicinal products (ATMPs) and those transgenically-derived under its umbrella....

FDA Draft Guidance Promotes the Use of QbD to Help Solve Residual Drug Problems in Transdermal Delivery Systems

FDA’s new draft guidance on transdermal and related drug delivery systems discusses the agency’s concerns with the residual drug left in the delivery systems after the intended use period and recommends manufacturers use quality-by-design (QbD) principles to minimize the problem for both new and existing products....

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