FDA Update on Traceback Related to the E. coli O157:H7 Outbreak Linked to Romaine Lettuce
By: Scott Gottlieb, M.D., and Stephen Ostroff, M.D. The FDA continues to investigate the outbreak of E. coli O157:H7 infections associated with romaine lettuce from the Yuma growing region. Any contaminated product from the Yuma growing region has already worked … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 1, 2018 Category: American Health Source Type: blogs
The FDA Issues Draft Guidance About the Absorption of Active Ingredients Being Considered for Inclusion in Over-the-Counter Drug Products Applied to the Skin and Marketed without Approved Applications
By: Theresa M. Michele, M.D. All drugs have some risk — even over-the-counter (OTC) drugs available without a prescription — and the FDA is always taking steps to help ensure their safety. When you take a pill, you generally expect … Continue reading → (Source: FDA Voice)
Source: FDA Voice - May 22, 2018 Category: American Health Source Type: blogs
Addressing Needs of Patients While Stemming the Tide of the Opioid Crisis
By: Scott Gottlieb, M.D. The biggest public health crisis facing FDA is opioid addiction. Not a day goes by in my role at FDA without hearing stories of the emotional, physical, and financial toll this epidemic is taking on Americans. … Continue reading → (Source: FDA Voice)
Source: FDA Voice - May 14, 2018 Category: American Health Source Type: blogs
Emerging issues of misuse and abuse of OTC loperamide challenge FDA to address a new turn in the opioid addiction crisis, while maintaining access for patients
By: Scott Gottlieb, M.D. The opioid epidemic has reached tragic proportions. Yet it continues to take many new, and troubling turns. If there’s one lesson we’ve learned from this crisis, it has been the ability of the mounting abuse and … Continue reading → (Source: FDA Voice)
Source: FDA Voice - May 10, 2018 Category: American Health Source Type: blogs
Spring Unified Agenda: FDA ’s Anticipated Upcoming Regulatory Work
By: Scott Gottlieb, M.D. Today, the federal government published the Spring 2018 “Unified Agenda of Federal Regulatory and Deregulatory Actions” (Unified Agenda), which provides federal agencies with the opportunity to update the American public on our government’s regulatory priorities. For … Continue reading → (Source: FDA Voice)
Source: FDA Voice - May 9, 2018 Category: American Health Source Type: blogs
The FDA is Asking for More Information on Application Forms — Here ’s Why That’s Good for Innovation and Improving Health
By: Christopher Leptak, M.D., Ph.D. To be most effective, electronic health records (EHRs) use a systematized and standardized nomenclature for the hundreds of thousands of clinical terms that characterize patient care. This helps to ensure consistency from EHR to EHR … Continue reading → (Source: FDA Voice)
Source: FDA Voice - May 4, 2018 Category: American Health Source Type: blogs
Food Information That ’s Pro Market and Pro Consumer
By: Scott Gottlieb, M.D. Information about how healthy our food is gives us the chance to make better choices about our diets. This same information also inspires competition among producers to formulate food in ways that make it more healthful. … Continue reading → (Source: FDA Voice)
Source: FDA Voice - May 2, 2018 Category: American Health Source Type: blogs
Mission Possible: Moving the Needle Forward to Advance Health Equity
By: CAPT Richardae Araojo Every April our country observes National Minority Health Month to spotlight what we’re doing to eliminate health disparities among minority populations. A health disparity is a particular type of health difference that is closely linked with … Continue reading → (Source: FDA Voice)
Source: FDA Voice - April 26, 2018 Category: American Health Source Type: blogs
New CDER Report Highlights Ongoing Drug Safety Initiatives and Priorities
By: Janet Woodcock, M.D. At FDA’s Center for Drug Evaluation and Research (CDER), drug safety is among our highest priorities. Before we approve a drug, we make every effort to ensure its benefits outweigh its risks. After approval, we keep … Continue reading → (Source: FDA Voice)
Source: FDA Voice - April 24, 2018 Category: American Health Source Type: blogs
Ironed Out
By: Vanessa Burrows During the early part of the 20th century, the growing scientific knowledge that certain diseases were caused by vitamin and mineral deficiencies sparked public interest in products that touted these substances. But the public had little understanding … Continue reading → (Source: FDA Voice)
Source: FDA Voice - April 13, 2018 Category: American Health Source Type: blogs
In Forum and On Farms, FDA and Partners Work to Harvest Agreement on Water Issues
By: Samir Assar, Ph.D. A two-day summit on the topic of agricultural water, followed by farm tours organized by FDA’s Produce Safety Network (PSN), illustrate FDA’s collaborative approach to implementing provisions of the FDA Food Safety Modernization Act (FSMA). The … Continue reading → (Source: FDA Voice)
Source: FDA Voice - April 2, 2018 Category: American Health Source Type: blogs
We ’re Committed to Guarding Against the Intentional Adulteration of Food and Implementing the New Rule Efficiently
By: Scott Gottlieb, M.D. The U.S. food supply is among the safest in the world. But to keep it safe we must recognize that our foods are vulnerable – not just from unintended contamination, but from those who would seek … Continue reading → (Source: FDA Voice)
Source: FDA Voice - March 28, 2018 Category: American Health Source Type: blogs
FDA Blood Supply and Demand Simulation Model Could Help Nation Prepare for Emergencies
By: Arianna Simonetti, Ph.D., and Richard Forshee, Ph.D. Keeping the nation’s blood supply and demand system working efficiently can be a matter of life and death. That often means moving blood to meet critical needs when an area of the … Continue reading → (Source: FDA Voice)
Source: FDA Voice - March 27, 2018 Category: American Health Source Type: blogs
FDA is Using Innovative Methods to Prevent Illegal Products with Hidden Drug Ingredients from Entering the United States
By: Scott Gottlieb, M.D., Melinda K. Plaisier, M.S.W., and Michael Kopcha, Ph.D., R.Ph. One of the Food and Drug Administration’s important public health functions is to closely monitor the FDA-regulated products arriving at the nation’s international mail facilities (IMFs) every … Continue reading → (Source: FDA Voice)
Source: FDA Voice - March 21, 2018 Category: American Health Source Type: blogs
FDA ’s New Pilot Program Aims for More Transparency about New Drug Approvals
By: Janet Woodcock, M.D. When FDA approves a new drug, it has been found safe and effective when used under the conditions described in the label. Although this concept seems simple, the execution can be complex. Many factors are involved … Continue reading → (Source: FDA Voice)
Source: FDA Voice - March 20, 2018 Category: American Health Source Type: blogs
