Our Goal in Enforcing Food Safety: A Rapid, Science-Based Response
By: Stephen Ostroff and Howard Sklamberg Recalls of potentially unsafe foods are an important food safety tool. The FDA most often works with companies to bring about voluntary recalls, with the goal of getting the product out of the marketplace … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 9, 2016 Category: American Health Source Type: blogs

Globalization and FDA’s New Partnerships to Ensure Product Safety
By: Howard Sklamberg Globalization is posing challenges for public health. For FDA, part of that challenge is the ever-increasing volume and complexity of FDA-regulated products coming to America’s shores. In fiscal year 2015, there were more than 34 million shipments … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 8, 2016 Category: American Health Source Type: blogs

Marking the Beginning of a New Era in Food Safety
By: Stephen Ostroff, M.D. The promises embodied in the FDA Food Safety Modernization Act (FSMA) add up to this: The foods that we eat and serve our families must be as safe as we can make them. These promises mandate … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 6, 2016 Category: American Health Source Type: blogs

A New Partnership with Canada on Food Safety
By: Caroline Smith DeWaal With a shared border that is more than 5,500 miles long, Canada and the United States have a lot in common — including a shared food supply. So it is no surprise that Canadian food safety … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 2, 2016 Category: American Health Source Type: blogs

Reducing Sodium in the Food Supply
By: Susan Mayne, Ph.D. As the former Chair of the Department of Chronic Disease Epidemiology at the Yale School of Public Health, I have looked critically at the totality of evidence on the link between sodium and chronic disease. The … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 1, 2016 Category: American Health Source Type: blogs

Celebrating a Year of the Expedited Access Pathway Program for Medical Devices
By: Erin Cutts, B.S., Owen Faris, Ph.D., and Jeffrey Shuren, M.D., J.D The U.S. Food and Drug Administration (FDA) is committed to supporting patient access to high-quality, safe, and effective medical devices of public health importance — as quickly as … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 1, 2016 Category: American Health Source Type: blogs

Unveiling the New Nutrition Facts Label
By: Robert M. Califf, M.D., and Susan Mayne, Ph.D. Today, the FDA has finalized the new Nutrition Facts label on packaged foods with changes that will make it easier for consumers to make informed choices about what they’re eating. Our … Continue reading → (Source: FDA Voice)
Source: FDA Voice - May 21, 2016 Category: American Health Source Type: blogs

From Competition to Collaboration: precisionFDA Challenges
By: Taha Kass-Hout, M.D., M.S., Zivana Tezak, Ph.D., and Elaine Johanson Next week, we will announce the winners of the first precisionFDA challenge. We set up precisionFDA as an online, cloud-based, virtual research space to allow scientists from academia, industry, … Continue reading → (Source: FDA Voice)
Source: FDA Voice - May 19, 2016 Category: American Health Source Type: blogs

Protecting Trade in Safe Food is a Global Concern
By: Sharon Mayl and Debbie Subera-Wiggin Protecting consumers from contaminated foods is a global concern—as well as a key FDA priority. This was clear to us when we attended a World Trade Organization (WTO) conference in Geneva earlier this spring … Continue reading → (Source: FDA Voice)
Source: FDA Voice - May 11, 2016 Category: American Health Source Type: blogs

What We Mean When We Talk About EvGen Part II: Building Out a National System for Evidence Generation
By: Rachel E. Sherman, M.D., M.P.H., and Robert M. Califf, M.D. In an earlier FDA Voice blog post, we discussed a pair of concepts – interoperability and connectivity – that are essential prerequisites for the creation of a successful national … Continue reading → (Source: FDA Voice)
Source: FDA Voice - May 3, 2016 Category: American Health Source Type: blogs

National Drug Take Back Day: A Great Time to Dispose of Prescription Medications Cluttering Your Cabinets
By: Douglas C. Throckmorton, M.D On Wednesday, April 27, FDA staff can bring in their unwanted, unused, or expired prescription drugs to the FDA campus for safe disposal as part of the Drug Enforcement Administration’s (DEA) National Prescription Drug Take … Continue reading → (Source: FDA Voice)
Source: FDA Voice - April 25, 2016 Category: American Health Source Type: blogs

Strengthening Partnerships: FDA’s China Office Engages in Key Outreach with Chinese Provincial FDA, Academia, and Industry
By: S. Leigh Verbois, Ph.D. 独木不成林,单弦不成音 Dú mù bù chéng lín, dān xián bù chéng yīn ‘A single tree makes no forest, one string makes no music.’ “A single tree makes no forest, one string makes no music.”This old Chinese … Continue reading → (Source: FDA Voice)
Source: FDA Voice - April 20, 2016 Category: American Health Source Type: blogs

What We Mean When We Talk About EvGen Part I: Laying the Foundation for a National System for Evidence Generation
By: Rachel E. Sherman, M.D., M.P.H., and Robert M. Califf, M.D. Across the clinical research enterprise, there is a growing awareness of serious shortfalls in the current paradigm of generating the scientific evidence that supports medical product evaluation and clinical … Continue reading → (Source: FDA Voice)
Source: FDA Voice - April 20, 2016 Category: American Health Source Type: blogs

Engagement and Collaborative Problem Solving: Two Ingredients for FSMA Success
By: Michael R. Taylor and Stephen Ostroff As we’ve developed the rules needed to implement the FDA Food Safety Modernization Act, we’ve done a great deal of outreach to explain the new requirements and obtain feedback from stakeholders. We’ve got … Continue reading → (Source: FDA Voice)
Source: FDA Voice - April 14, 2016 Category: American Health Source Type: blogs

2015: An Important Year for Advancing Generic Drugs at FDA
By: Kathleen “Cook” Uhl, M.D. Generic drugs allow greater access to health care for all Americans. At FDA’s Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research, 2015 was an important year. It was our first … Continue reading → (Source: FDA Voice)
Source: FDA Voice - April 13, 2016 Category: American Health Source Type: blogs