CDER?s Division of Post-Marketing Evaluation for Quality Assessment
July 1st 2006The new Division of Post Marketing Evaluation in the Office of New Drug Quality Assessment has implemented an improved system for managing the submission and review processes for post approval chemistry, manufacturing, and controls change supplements.
Bruker Daltonics obtains Russian Medical Device Registration
July 1st 2006Bruker Daltonics Inc. (Billerica, Massachusetts) announced that it has obtained registration of its MALDI-TOF product line of microflex, autoflex TOF or TOF/TOF, and ultraflex TOF/TOF mass spectrometers as medical devices from the Ministry of Health and Social Development of the Russian Federation.
Renewal of distribution partnership
July 1st 2006NEXUS Biosystems has announced that it has renewed its worldwide marketing agreement with Bruker AXS to continue to globally market, sell and support the NEXUS Crystal Farm line of products. The range of products is an expanding line of automated instrumentation focused on protein crystallography research.
DESI, IMS and Resurgent Challenges to HPLC–MS
July 1st 2006Liquid chromatography–mass spectrometry (LC–MS) has been increasingly indispensable in most analytical pursuits. Such acceptance would not have occurred without encouraging, early academic efforts and also the efforts of early practitioners who pressed manufacturers to improve and extend electrospray's capabilities. I briefly described the commercialization of LC in its halcyon period of the early 1990s in a 1998 article.¹