CDER FDA Report Says CDER Needs Better Understanding of Drug Response Markers Premium "We need to improve our understanding of the safety and efficacy of pharmacotherapy as it applies to individual patients and patient subsets," the agency states in a report released this week. CDRH Seeks Comments on 510(k) Device Process The centers will hold a public meeting and take comments on its 25-point plan to enhance and streamline its medical devices submission process. Industry Stakeholders Hope for Introduction of 'Advanced Diagnostics' Bill in Congress This Year Premium "It's a beautifully constructed bill that has been carefully put together. We hope it might get introduced this year." Q&A: FDA's Zineh Reviews 2010 Personalized Rx Efforts and Discusses Future Plans Premium Zineh recently answered PGx Reporter's questions about the agency's efforts in pharmacogenomics and personalized medicine. FDA Official Offers Advice on Regulatory Path for Companion Diagnostics Premium At an industry conference last week, a scientific reviewer at FDA's Office of In Vitro Diagnostics Device Evaluation and Safety discussed detailed strategies for navigating the regulatory process for Rx/Dx combination products. Nov 11, 2009 FDA Top Officials Discuss Ongoing Efforts to Bring Agency Into Genomics Era Premium Sep 9, 2009 FDA Releases Draft Guidance for HPV IVD Tests Apr 22, 2009 FDA May Issue More White Papers on Rx/Dx Codevelopment, Woodcock Says At Meeting Premium Mar 25, 2009 Large UK GWAS Underscores Impact of CYP2C9, VKORC1, New SNP in Warfarin-Dosing Variability Premium Feb 19, 2009 Genetics Improves Some Warfarin Dosing; Clinical Trials Next Feb 18, 2009 NIH Launches Large Randomized Trial to Determine Utility of PGx-based Warfarin Dosing Premium Feb 18, 2009 Serious Adverse Events Consortium Releases First Data Set on Genes Linked to Stevens-Johnson Syndrome Premium Breaking News Ancient DNA Analysis Highlights Three Ancestral Populations in Japan FDA Warns of Potential False Positives With Abbott SARS-CoV-2 Molecular Tests New Products Posted to GenomeWeb: Oxford Nanopore, Beckman Coulter, Thermo Fisher Scientific, More People in the News: New Appointments at Sema4, NHGRI, Dante Labs, Ancestry, More Thermo Fisher Scientific Expects 12 Percent Revenue Growth in 2022 In Brief This Week: Myriad Genetics, Danaher, Co-Diagnostics, and More The Scan For Those Thick Tiger Stripes Tigers in India with thick stripes harbor a genetic change, as Gizmodo reports. High GABA Tomatoes The Japan News reports that genome-edited tomatoes with higher GABA levels are now for sale in Japan. Approach for Inclusivity and Diversity A National Human Genome Research Institute team calls for the field to "adopt diversity as an ethos." Science Papers on Tumors Immune System Evasion; Drivers of Genomic Instability, Inflammation In Science this week: study of how tumors evade the adaptive immune system, and more.