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 - February 25, 2017 Category: American Health Source Type: blogs
National Medical Evidence Generation Collaborative (EvGen Collaborative)
By: Rachel E. Sherman, M.D., M.P.H., and Robert M. Califf, M.D. Readers of FDAVoice may have noticed that we’ve been talking a lot lately about the topic of evidence generation (for example, see here and here). Scientific evidence—how it’s created, … Continue reading → (Source: FDA Voice)
Source: FDA Voice - February 25, 2017 Category: American Health Source Type: blogs
Introducing IMEDS, a Public-Private Resource for Evidence Generation
By: Robert M. Califf, M.D. FDA has been working to establish a national resource for FDA-approved medical products that can be used by public and private-sector entities, including regulated industry, to conduct large scale evaluations of safety issues in an … Continue reading → (Source: FDA Voice)
Source: FDA Voice - February 25, 2017 Category: American Health Source Type: blogs
FDA ’s Science-based Approach to Genome Edited Products
By Robert M. Califf M.D., and Ritu Nalubola, Ph.D. Recent scientific advances now make it possible to more efficiently and precisely alter the genome of plants, animals, and microorganisms to produce desired traits. These genome editing technologies are relatively easy to … Continue reading → (Source: FDA Voice)
Source: FDA Voice - February 25, 2017 Category: American Health Source Type: blogs
FDA Advisory Committees: Independent, Informed, Essential, and Evolving
By: Robert M. Califf, M.D. One of the most common concerns raised when I meet with medical leaders is the need to improve the function of FDA’s Advisory Committees (ACs). ACs play a key role in FDA’s decision-making process by … Continue reading → (Source: FDA Voice)
Source: FDA Voice - February 25, 2017 Category: American Health Source Type: blogs
Working Together to Reduce the Devastating Effects of Opioid Misuse
By Robert M. Califf, M.D. The public health crisis of opioid misuse, addiction and overdose is one of the most challenging issues the U.S. Food and Drug Administration has faced during my time as FDA commissioner. Solving this issue is … Continue reading → (Source: FDA Voice)
Source: FDA Voice - February 25, 2017 Category: American Health Source Type: blogs
Mixing Kentucky Spirits with Food Safety to Protect Spent Grains Used to Feed Animals
By: Jenny Murphy, M.S. “Spent grains” is the general term for the remnants of corn, rye, barley and other grains used to make alcoholic beverages. While they are a byproduct of human-food production, spent grains have a long history of … Continue reading → (Source: FDA Voice)
Source: FDA Voice - February 25, 2017 Category: American Health Source Type: blogs
FDA Drug Trials Snapshots and Diversity When Testing New Drugs
By: John J. Whyte, M.D., M.P.H. Did you know that some drugs affect men and women differently? For instance, women are often prescribed only half the dose that men take of the sleep medication, Ambien (zolpidem). Race and ethnicity also … Continue reading → (Source: FDA Voice)
Source: FDA Voice - February 25, 2017 Category: American Health Source Type: blogs
2016: A Record-setting Year for Generic Drugs
By: Kathleen “Cook” Uhl, M.D. Over the last 10 years, generic drugs have saved the U.S. healthcare system about $1.68 trillion. I’m pleased to report that 2016 was a record-setting year for FDA’s generic drug program, a result that will … Continue reading → (Source: FDA Voice)
Source: FDA Voice - February 25, 2017 Category: American Health Source Type: blogs
FDA Drug Trials Snapshots and Diversity When Testing New Drugs
By: John J. Whyte, M.D., M.P.H. Did you know that some drugs affect men and women differently? For instance, women are often prescribed only half the dose that men take of the sleep medication, Ambien (zolpidem). Race and ethnicity also … Continue reading → (Source: FDA Voice)
Source: FDA Voice - February 14, 2017 Category: American Health Source Type: blogs
Mixing Kentucky Spirits with Food Safety to Protect Spent Grains Used to Feed Animals
By: Jenny Murphy, M.S. “Spent grains” is the general term for the remnants of corn, rye, barley and other grains used to make alcoholic beverages. While they are a byproduct of human-food production, spent grains have a long history of … Continue reading → (Source: FDA Voice)
Source: FDA Voice - January 27, 2017 Category: American Health Source Type: blogs
FDA Advisory Committees: Independent, Informed, Essential, and Evolving
By: Robert M. Califf, M.D. One of the most common concerns raised when I meet with medical leaders is the need to improve the function of FDA’s Advisory Committees (ACs). ACs play a key role in FDA’s decision-making process by … Continue reading → (Source: FDA Voice)
Source: FDA Voice - January 19, 2017 Category: American Health Source Type: blogs
FDA ’s Science-based Approach to Genome Edited Products
By Robert M. Califf M.D., and Ritu Nalubola, Ph.D. Recent scientific advances now make it possible to more efficiently and precisely alter the genome of plants, animals, and microorganisms to produce desired traits. These genome editing technologies are relatively easy to … Continue reading → (Source: FDA Voice)
Source: FDA Voice - January 18, 2017 Category: American Health Source Type: blogs
National Medical Evidence Generation Collaborative (EvGen Collaborative)
By: Rachel E. Sherman, M.D., M.P.H., and Robert M. Califf, M.D. Readers of FDAVoice may have noticed that we’ve been talking a lot lately about the topic of evidence generation (for example, see here and here). Scientific evidence—how it’s created, … Continue reading → (Source: FDA Voice)
Source: FDA Voice - January 17, 2017 Category: American Health Source Type: blogs
Introducing IMEDS, a Public-Private Resource for Evidence Generation
By: Robert M. Califf, M.D. FDA has been working to establish a national resource for FDA-approved medical products that can be used by public and private-sector entities, including regulated industry, to conduct large scale evaluations of safety issues in an … Continue reading → (Source: FDA Voice)
Source: FDA Voice - January 17, 2017 Category: American Health Source Type: blogs
