FDA-Patented Invention Earns 2016 Patents for Humanity Award for Impact on Global Public Health
By: Carolyn A. Wilson, Ph.D., and Alice Welch, Ph.D. In 2003, two scientists in FDA’s Office of Vaccines Research and Review within the Center for Biologics Evaluation and Research (CBER) developed a pivotal step in the manufacture of a vaccine … Continue reading → (Source: FDA Voice)
Source: FDA Voice - January 10, 2017 Category: American Health Source Type: blogs
A Review of CDER ’s Novel Drug Approvals for 2016
By: John Jenkins, M.D. This past year was another successful year for the new drugs program in FDA’s Center for Drug Evaluation and Research (CDER). CDER reviewed and approved 22 novel drugs, most of which have the potential to add … Continue reading → (Source: FDA Voice)
Source: FDA Voice - January 4, 2017 Category: American Health Source Type: blogs
Managing Medical Device Cybersecurity in the Postmarket: At the Crossroads of Cyber-safety and Advancing Technology
By: Suzanne B. Schwartz, M.D., M.B.A. Protecting medical devices from ever-shifting cybersecurity threats requires an all-out, lifecycle approach that begins with early product development and extends throughout the product’s lifespan. Today, we’re pleased to announce that industry now has advice … Continue reading → (Source: FDA Voice)
Source: FDA Voice - December 27, 2016 Category: American Health Source Type: blogs
Clacker Balls and the Early Days of Federal Toy Safety
By: John P. Swann, Ph. D. As many of us scramble to find the perfect toy for the children in our lives this holiday season, it’s interesting to note that at one time FDA could very well have been known … Continue reading → (Source: FDA Voice)
Source: FDA Voice - December 22, 2016 Category: American Health Source Type: blogs
Academic Medical Centers and FDA – Working Together for the Future
By: Robert M. Califf, M.D. FDA and the nation’s academic medical centers (AMCs) have a rich history together. Many of us at FDA trained and worked at AMCs, and many of us will go back to AMCs when we leave … Continue reading → (Source: FDA Voice)
Source: FDA Voice - December 19, 2016 Category: American Health Source Type: blogs
FDA ’s Naloxone App Prize Competition Celebrates Innovation In Search of Technological Solutions to the Opioid Epidemic
By: Peter Lurie, M.D., M.P.H. The epidemic of opioid dependence and abuse has had an impact upon communities both large and small across the United States. Since 1999, rates of overdose deaths involving opioids, whether prescription painkillers or street drugs … Continue reading → (Source: FDA Voice)
Source: FDA Voice - December 15, 2016 Category: American Health Source Type: blogs
Better Tool to Help Assess LASIK Patients
By: Malvina Eydelman, MD LASIK (laser-assisted in situ keratomileusis) eye surgery is an alternative for patients who need glasses or contacts to see well. Some 600,000 to 800,000 patients undergo LASIK in the U.S. each year, and a very high … Continue reading → (Source: FDA Voice)
Source: FDA Voice - December 14, 2016 Category: American Health Source Type: blogs
21st Century Cures Act: Making Progress on Shared Goals for Patients
By: Robert M. Califf, M.D. Today, President Obama signed into law the 21st Century Cures Act, which, I am pleased to report, builds on FDA’s ongoing efforts to advance medical product innovation and ensure that patients get access to treatments … Continue reading → (Source: FDA Voice)
Source: FDA Voice - December 14, 2016 Category: American Health Source Type: blogs
Faster Information from FDA Means Improved Drug Safety for Patients
Mary E. Kremzner, PharmD, MPH, CAPT, U.S. Public Health Service FDA is now making it easier and faster for health care professionals and patients to get the most up-to-date drug safety information on the more than 18,000 drugs available on … Continue reading → (Source: FDA Voice)
Source: FDA Voice - December 12, 2016 Category: American Health Source Type: blogs
The Mutual Reliance Initiative: A New Path for Pharmaceutical Inspections in Europe and Beyond
By: Dara Corrigan, J.D. For FDA professionals focused on drug quality and safety, the rapid increase in imported drugs from nations where we devote limited inspection resources is of great concern. One way to address this concern would be to … Continue reading → (Source: FDA Voice)
Source: FDA Voice - December 7, 2016 Category: American Health Source Type: blogs
Why FDA Is Making Data Extracted from Reports of Adverse Events for Foods and Cosmetics Available to the Public
By: Susan Mayne, Ph.D., and Katherine Vierk, M.P.H. Transparency in the actions we take as an agency, and our reasons for taking them, is an important value for FDA in its mission to protect public health. That is why we … Continue reading → (Source: FDA Voice)
Source: FDA Voice - December 7, 2016 Category: American Health Source Type: blogs
Combination Products Review Program: Progress and Potential
By: Nina L. Hunter, Ph.D., and Robert M. Califf, M.D. About a year ago, we shared with you our Combination Product Review, Intercenter Consult Process Study Report, which was developed by FDA’s Office of Planning. The report’s findings were derived … Continue reading → (Source: FDA Voice)
Source: FDA Voice - December 3, 2016 Category: American Health Source Type: blogs
Trade Alert: FDA Issues New Import Data Requirements
By: Howard Sklamberg, J.D. One of FDA’s many responsibilities is to review imported products regulated by the agency to determine admissibility. This job has become increasingly challenging with growing volumes of imports of FDA-regulated products each year — from six … Continue reading → (Source: FDA Voice)
Source: FDA Voice - November 30, 2016 Category: American Health Source Type: blogs
FDA ’s Sunscreen Guidance outlines safety and effectiveness data recommended for additional active ingredients
By: Theresa M. Michele, M.D. American consumers rely extensively on over-the-counter (OTC) sunscreens to help prevent sunburn. Certain sunscreens are also used, along with other protective measures, to reduce the risks of skin cancer and early skin aging caused by … Continue reading → (Source: FDA Voice)
Source: FDA Voice - November 22, 2016 Category: American Health Source Type: blogs
Visit to West Coast Farmers and Processors Finds Shared Commitment to Food Safety
By: Stephen Ostroff, M.D. Most people, even if they live in cities or suburbs, understand that there are many types of farms. But to really appreciate how different farms can be, you have to get out there and see it … Continue reading → (Source: FDA Voice)
Source: FDA Voice - November 11, 2016 Category: American Health Source Type: blogs
