http://faegrebdc.com/fda en-us Copyright 2000-16 FaegreBD Consulting. All Rights Reserved. http://blogs.law.harvard.edu/tech/rss 11/28/2016 4:04:35 AM In an article for Drug Topics, FaegreBD Consulting principal Libby Baney explained how healthcare providers can enroll in educational courses to learn about the dangers of illegal online pharmacies and better understand how to source medications... http://faegrebdc.com/libby-baney-discusses-how-to-bridge-online-pharmacy-methods-with 22 Nov 2016 00:00:00:000 In an article for The Atlantic, Faegre Baker Daniels counsel Libby Baney shared her concerns for transgender people who purchase drugs from online pharmacies. She warned that about a half of these online pharmacies are selling counterfeit drugs. http://faegrebdc.com/libby-baney-quoted-in-the-atlantic-about-online-pharmacies-and 06 Sep 2016 00:00:00:000 The Food and Drug Administration (FDA) released a final guidance on July 29, 2016, saying that it does not plan to require pre-market review for low-risk "general wellness products," such as wearable fitness monitors, pedometers and sleep trackers... http://faegrebdc.com/christmas-in-july-for-wellness-apps-and-devices 01 Aug 2016 00:00:00:000 Samantha N. Strong has joined FaegreBD Consulting as an advisor with the health and biosciences team in Washington, D.C. Strong brings a strong focus on government advocacy. Grounded in pragmatic choices and political implications, she combines... http://faegrebdc.com/samantha-strong-brings-bioethics-background-to-faegrebd-consulting 31 May 2016 00:00:00:000 Kelly M. Nickel has joined FaegreBD Consulting as an advisor with the health and biosciences team in Washington, D.C. Nickel brings a range of experience in health care and advocacy circles. Her diverse background in today’s complex government... http://faegrebdc.com/kelly-nickel-brings-diverse-background-to-health-and-biosciences-team 20 Mar 2016 00:00:00:000 Molecular diagnostic testing is a fast-developing frontier in medical care that already plays a major role in oncology, infectious disease and a number of other medical fields. At the fourth annual meeting of Patient-Centered Oncology Care, FaegreBD... http://faegrebdc.com/bruce-quinn-professional-societies-should-drive-development-of-diagnostic-testing 08 Mar 2016 00:00:00:000 Bruce Quinn of FaegreBD Consulting will be the opening speaker at the Integrating Personalized Medicine Into Health Care Summit on October 14, 2015, at the Renaissance Hotel in Washington, D.C. His presentation will address “Meeting the Challenges... http://faegrebdc.com/integrating-personalized-medicine-into-health-care 14 Oct 2015 00:00:00:000 On June 6, 2015, FDA released draft guidance on Duchenne Muscular Dystrophy. This draft guidance was significant because it was proposed and drafted by the Parent Project Muscular Dystrophy (PPMD) then given to the Food and Drug Administration (FDA)... http://faegrebdc.com/patient-engagement-in-the-fda-process 30 Sep 2015 00:00:00:000 Lauren K. Bloch has joined FaegreBD Consulting as an advisor with the firm’s health and biosciences team in Washington, D.C., following multiple positions as a management consultant and project manager at the U.S. Departments of Health and Human... http://faegrebdc.com/lauren-bloch-brings-coalition-project-management-to-health-biosciences-team 24 Sep 2015 00:00:00:000 Bruce Quinn, M.D., Ph.D., has joined FaegreBD Consulting as a senior director with the firm’s health and biosciences team in Washington, D.C., where he leads the firm’s health markets and reimbursement strategy consulting practice. He has offices in... http://faegrebdc.com/health-markets-reimbursement-policy-expert-bruce-quinn-md-phd-joins 20 Jul 2015 00:00:00:000 A boost for authorized funding for the National Institutes of Health (NIH), a new $10 billion innovation fund at NIH and a paring back of many drug development incentives are among the many changes unveiled in the second draft of the 21st Century... http://faegrebdc.com/more-funding-less-drug-development-incentives-unveiled-in-21st-century 30 Apr 2015 00:00:00:000 FaegreBD Consulting senior director Libby Baney and Faegre Baker Daniels partner Lee Tumminello are presenting a MichBioU webinar entitled, “Working With Advocacy Groups and Board: Top 5 Compliance and Operational Best Practices,” on Wednesday... http://faegrebdc.com/michbio-u-advocacy-groups-advisory-boards-best-practices 11 Mar 2015 00:00:00:000 The U.S. House Energy & Commerce Committee on January 27, 2015, released its much-anticipated 21st Century Cures discussion draft. The nearly 400-page bill includes more than 100 provisions across five titles and focuses significantly on reforms... http://faegrebdc.com/long-awaited-21st-century-cures-draft-released-what-does-the 28 Jan 2015 00:00:00:000 Debra Lappin, principal at FaegreBD Consulting and president of the Council for American Medical Innovation, will moderate the first panel discussion, "Exploring New Avenues to Accelerate Research," during the 11th annual Indiana Life Sciences... http://faegrebdc.com/indiana-life-sciences-summit 15 Oct 2014 00:00:00:000 On Thursday, June 26, 2014, the U.S. Food and Drug Administration (FDA) held a public meeting in Washington, D.C. to discuss the two proposed rule changes to the Nutrition Facts panels seen on most packaged foods in the U.S. These would be the first... http://faegrebdc.com/proposed-changes-to-nutrition-facts-panels-discussed-at-fda-public 02 Jul 2014 00:00:00:000 Ralph Hall of FaegreBD Consulting discussed the advent of the International Medical Device Regulators Forum (IMDRF) and analyzed its potential for playing a significant role in the marketplace in the March 2014 issue of BioFutures (page 24), the... http://faegrebdc.com/the-new-regulator-the-rise-of-imdrf 25 Apr 2014 00:00:00:000 Business is back to normal — or close to normal — for the Food and Drug Administration's Center for Devices and Radiological Health (CDRH) tasked with reviewing and clearing all medical devices. But while the center is operating, stakeholders need... http://faegrebdc.com/what-reopening-of-the-government-means-for-medical-device-stakeholders 18 Oct 2013 00:00:00:000 Today, the U.S. Food and Drug Administration (FDA) announced that they would extend for 120 days the comment period for two proposed rules that were promulgated as part of the implementation of the Food Safety Modernization Act (FSMA). The... http://faegrebdc.com/fda-extends-comment-period-for-proposed-food-safety-rules-on 24 Apr 2013 00:00:00:000 Allison E. Durham has joined FaegreBD Consulting as a public policy specialist in the health and biosciences practice group in the firm's Washington, D.C. office. Prior to joining FaegreBD Consulting, Durham earned a Master of Science degree from... http://faegrebdc.com/allison-durham-joins-health-biosciences-group-at-faegrebd-consulting 31 Oct 2012 00:00:00:000 The first reports regarding payments or transfers of value to physicians by the health care industry are due in less than a year, as required by the Physician Payment Sunshine Act. Join a panel of health care experts, including Ralph Hall of... http://faegrebdc.com/the-sunshine-act-best-practices-for-industry-compliance-and-the 12 Sep 2012 00:00:00:000 Join the Center for Telehealth and e-Health Law for a brown bag webinar featuring Libby Baney of FaegreBD Consulting, who advises the Alliance for Safe Online Pharmacies (ASOP). Libby will address issues related to Internet and telemedicine... http://faegrebdc.com/what-does-congress-have-to-say-about-telemedicine-prescribing 25 Jun 2012 00:00:00:000 For 30 years, Faegre & Benson's government relations practice has represented regional and national clients on a full range of public policy issues in Minnesota. Clients on whose behalf we have worked know us for our expertise, integrity and ability... http://faegrebdc.com/government-relations-an-expanded-array-of-services 01 Feb 2012 00:00:00:000