The Race to bring Penicillin to the Troops in WWII
By: John P. Swann, Ph.D. This Veterans Day we remember that nearly 75 years ago dozens of American academic, commercial, nonprofit, and governmental institutions – including FDA – joined together in a race to provide a promising but complex and … Continue reading → (Source: FDA Voice)
Source: FDA Voice - November 8, 2016 Category: American Health Source Type: blogs
Consumer expenditure on FDA regulated products: 20 cents of every dollar
By: Sheri Walker, Ph.D., and Clark Nardinelli One of the much-cited statistics about FDA is this: that FDA-regulated products account for about 20 cents of every dollar of annual spending by U.S. consumers. Add up 20 cents of every dollar … Continue reading → (Source: FDA Voice)
Source: FDA Voice - November 1, 2016 Category: American Health Source Type: blogs
Key Facts about “Abuse-Deterrent” Opioids
By: Douglas C. Throckmorton, M.D. Here at FDA, we work diligently to be part of our nation’s solution to the opioid abuse epidemic. While there is no single solution to this complex problem, we continue to encourage efforts to develop … Continue reading → (Source: FDA Voice)
Source: FDA Voice - October 29, 2016 Category: American Health Source Type: blogs
National Cyber Security Awareness Month: Understanding the Interdependencies of Medical Devices and Cybersecurity
By: Suzanne B. Schwartz, M.D., M.B.A. October is National Cybersecurity Awareness Month. Proclaimed by President Obama each year, Cybersecurity Awareness Month encourages the public and industry to understand the importance of cybersecurity and to be vigilant when it comes to … Continue reading → (Source: FDA Voice)
Source: FDA Voice - October 27, 2016 Category: American Health Source Type: blogs
SCORE at Six Months: Meeting the Challenge of Complex Recalls
By: Stephen Ostroff, M.D., and Howard Sklamberg, J.D. When a potentially contaminated food is on the market, time is of the essence to keep people from becoming ill. Yet there are times when it is difficult to determine what actions … Continue reading → (Source: FDA Voice)
Source: FDA Voice - October 25, 2016 Category: American Health Source Type: blogs
FDA is working with hospitals to modernize data collection about medical devices
Jeffrey Shuren, M.D., J.D., Director of FDA’s Center for Devices and Radiological Health By: Jeffrey Shuren, M.D., J.D. America’s hospitals and their dedicated staff helps us fight disease and suffering by delivering life-saving and life-enhancing care every day in an … Continue reading → (Source: FDA Voice)
Source: FDA Voice - October 24, 2016 Category: American Health Source Type: blogs
FDA ’s Opioids Action Plan: A Midyear Checkup
By: Robert M. Califf, M.D. As FDA works to address the opioid epidemic of abuse, misuse and addiction, it’s valuable to see firsthand some of the ways the crisis is affecting our communities. This summer, I toured areas hard-hit by … Continue reading → (Source: FDA Voice)
Source: FDA Voice - October 24, 2016 Category: American Health Source Type: blogs
Introducing FDA ’s Emerging Sciences Idea Portal: Please Help Us Predict the Future
By: Donna L. Mendrick, Ph.D. Gazing into the future to predict the next new things in science and technology is not just the work of a science fiction writer. Government and business engage in this forward thinking too– it’s called … Continue reading → (Source: FDA Voice)
Source: FDA Voice - October 19, 2016 Category: American Health Source Type: blogs
New FDA/EMA rare diseases and patient engagement clusters underway
By: Jonathan Goldsmith, M.D., FACP, and Sandy Kweder, M.D., RADM (Ret.) US Public Health Service Drug development and approval happens across the globe and we at FDA strive to collaborate with other countries and international regulatory agencies to ensure public … Continue reading → (Source: FDA Voice)
Source: FDA Voice - October 18, 2016 Category: American Health Source Type: blogs
Where We Are/What We Have Done – Two Years After Releasing Our FDASIA 907 Action Plan
By: Janice Soreth, M.D. Since it’s been more than two years since FDA unveiled its Action Plan to advance the inclusion of diverse populations in clinical trials, we’d like to update you on how much we have accomplished, and acknowledge … Continue reading → (Source: FDA Voice)
Source: FDA Voice - October 12, 2016 Category: American Health Source Type: blogs
Our 20th Patient-Focused Drug Development meeting: Enhancing the patient ’s voice in FDA’s approach to drug review and development
By: Theresa M. Mullin, Ph.D. Since the launch of the Patient Focused Drug Development program as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V), we have worked intensively to explore ways to enhance the … Continue reading → (Source: FDA Voice)
Source: FDA Voice - October 4, 2016 Category: American Health Source Type: blogs
precisionFDA ’s Next Challenge? Conduct an App-a-Thon!
By: Zivana Tezak, Ph.D., and Elaine Johanson FDA is increasingly harnessing the power of supercomputers, the creative and collaborative culture of the scientific community, and novel approaches to technology to help achieve advances in diagnostics, therapeutics, and analytics that will … Continue reading → (Source: FDA Voice)
Source: FDA Voice - October 3, 2016 Category: American Health Source Type: blogs
Using Symbols to Convey Information in Medical Device Labeling
By: Antoinette (Tosia) Hazlett, MSN, RN, and Scott Colburn CAPT, USPHS Symbols convey important messages for navigating everyday life; whether it’s a traffic sign or a graphic image indicating that no smoking is allowed in a building. Symbols in medical … Continue reading → (Source: FDA Voice)
Source: FDA Voice - September 30, 2016 Category: American Health Source Type: blogs
FDA ’s Clinical Investigator Training Helps Support the Drug Development Process
By: Leonard Sacks, M.D., and Mili Duggal, Ph.D., M.P.H. Though many people do not know it, FDA does much more to facilitate drug approval than evaluate new drug applications. We are also actively involved in drug development well before the … Continue reading → (Source: FDA Voice)
Source: FDA Voice - September 28, 2016 Category: American Health Source Type: blogs
Making Sure ‘Healthy’ Means What It Says on Food Packages
By: Douglas Balentine, Ph.D. With final rules on the Nutrition Facts label published, consumers soon will see an updated label on food packages that makes the calories and serving sizes of products easier to see and that gives them additional … Continue reading → (Source: FDA Voice)
Source: FDA Voice - September 27, 2016 Category: American Health Source Type: blogs
