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Tips To Reduce Timelines In Integrated Summaries Of Safety And Effectiveness

By David Underwood An ISS is an integrated summary of safety, and an ISE is an integrated summary of effectiveness. An ISS combines the safety…

TAP For CRT — Challenges Due To Product Temperature Criteria

By Ken Maltas and Iftekhar Ahmed There has been significant discussion over the past few years around TAP (temperature-assured packaging) for CRT (controlled-room temperature). Manufacturers…

Greater Cold Chain Controls Through Enabling Technology

By David Bang The term cold chain refers to the time-and-temperature-controlled transportation of temperature-sensitive products from the manufacturer to the end user. The goal of…