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11, 2009 FDA Top Officials Discuss Ongoing Efforts to Bring Agency Into Genomics Era Premium Sep 9, 2009 FDA Releases Draft Guidance for HPV IVD Tests Apr 22, 2009 FDA May Issue More White Papers on Rx/Dx Codevelopment, Woodcock Says At Meeting Premium Mar 25, 2009 Large UK GWAS Underscores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 Pediatric Medulloblastoma Subgroups May Benefit from Lower-Dose Radiation Therapy Space Radiation Shows Limited Effects on Mammalian Sperm DNA, Fertility Bluestar Genomics Sues Former Consultant, Ludwig Institute for Cancer Research Over IP Ownership New Products Posted to GenomeWeb: 10x Genomics, Swift Biosciences, Agilent Technologies, More In Brief This Week: Quantum-Si, TGen, Yale, and More People in the News: New Appointments at Invitae, PGDx, Oxford Nanopore, PacBio, More The Scan Fertility Fraud Found Consumer genetic testing has uncovered cases of fertility fraud that are leading to lawsuits, according to USA Today. Ties Between Vigorous Exercise, ALS in Genetically At-Risk People Regular strenuous exercise could contribute to motor neuron disease development among those already at genetic risk, Sky News reports. Test Warning The Guardian writes that the US regulators have warned against using a rapid COVID-19 test that is a key part of mass testing in the UK. Science Papers Examine Feedback Mechanism Affecting Xist, Continuous Health Monitoring for Precision Medicine In Science this week: analysis of cis confinement of the X-inactive specific transcript, and more.