CBER’s Laboratory Quality System Management Helps Keep Biological Product Standards High
By: Peter Marks, M.D., Ph.D. Part of the vision of the Center for Biologics Evaluation and Research (CBER) is to strengthen the Center as the preeminent regulatory organization for biologics. One way CBER is achieving this: Through the work of … Continue reading → (Source: FDA Voice)
Source: FDA Voice - February 19, 2016 Category: American Health Source Type: blogs
FDA Offers Free, Continuing Education Course to Help Health Care Providers Understand ‘Biosimilars’
By: Leah Christl, Ph.D. You may have heard about a new category of products called “biosimilars.” What are biosimilars and how do they relate to biological products already widely in use? Biological products derived from living organisms can treat patients … Continue reading → (Source: FDA Voice)
Source: FDA Voice - February 19, 2016 Category: American Health Source Type: blogs
What is FDA Doing to Improve the Health of African-Americans?
By: Jovonni Spinner, M.P.H., C.H.E.S. Every February, we celebrate Black History Month – a time to reflect, celebrate, and honor the contributions of African-Americans to our society. We know that achieving and maintaining good health is a long-standing issue for … Continue reading → (Source: FDA Voice)
Source: FDA Voice - February 17, 2016 Category: American Health Source Type: blogs
Clarifying What We Mean When We Talk About Biomarkers: An NIH/FDA Joint Leadership Council Success
By: Melissa A. Robb, B.S.N., M.S. (RegSci), and Robert M. Califf, M.D. What if there was a more uniform way to convey key technical terms to help advance scientific progress? Thanks to the Biomarkers, Endpoints, and other Tools (BEST) Resource, … Continue reading → (Source: FDA Voice)
Source: FDA Voice - February 13, 2016 Category: American Health Source Type: blogs
Using Social Media to Teach Consumers About Heart Health
By: Jonca Bull, M.D. February is American Heart Month. Heart disease remains a significant problem in the United States – it’s the leading cause of death, disproportionately affecting minorities. In particular, minorities have higher rates of hypertension, diabetes, and smoking, … Continue reading → (Source: FDA Voice)
Source: FDA Voice - February 9, 2016 Category: American Health Source Type: blogs
Building a Case for Medical Device Interoperability: FDA’s Call to Action
By: Bakul Patel, M.S., M.B.A. As Yoda might say: build a case for interoperability, we must. While we may not have yet realized the technological accomplishments of Yoda’s advanced world, today connectivity shows great promise for the future. From blood … Continue reading → (Source: FDA Voice)
Source: FDA Voice - February 9, 2016 Category: American Health Source Type: blogs
Changing course: A new approach to opioid pain medication at FDA
By: Robert M. Califf, M.D. As a doctor, I have a first-hand understanding of the important and legitimate need for powerful medication to help people deal with chronic or severe pain. If you have had a family member or loved … Continue reading → (Source: FDA Voice)
Source: FDA Voice - February 6, 2016 Category: American Health Source Type: blogs
Building a Modern Generic Drug Review Process
By: Stephen Ostroff, M.D. Recent hearings on Capitol Hill highlighted an issue of growing importance for patients and for public health: access to quality, affordable medicines, in particular generic drugs. FDA’s generic drug program promotes access to quality affordable medicines … Continue reading → (Source: FDA Voice)
Source: FDA Voice - February 5, 2016 Category: American Health Source Type: blogs
Modernizing Pharmaceutical Manufacturing to Improve Drug Quality: Ensuring a Safe and Adequate Supply of Drugs
By: Michael Kopcha, Ph.D., R.Ph. FDA is working with drug makers in a new way to help the industry adopt scientifically sound, novel technologies to produce quality medicines that are consistently safe and effective — with an eye toward avoiding … Continue reading → (Source: FDA Voice)
Source: FDA Voice - February 2, 2016 Category: American Health Source Type: blogs
2016: The Year of Diversity in Clinical Trials
By: Robert M. Califf, M.D. Controlled clinical trials provide a critical base of evidence for evaluating whether a medical product is effective before the product is approved for marketing. One challenge that remains for FDA is ensuring that research participants … Continue reading → (Source: FDA Voice)
Source: FDA Voice - January 30, 2016 Category: American Health Source Type: blogs
FDA Enforcement: Protecting Consumers and Enhancing Public Confidence
By: Howard Sklamberg, J.D. and Michael R. Taylor, J.D. Under the Federal Food, Drug, and Cosmetic Act, companies producing food, including dietary supplement products, for American consumers have a legal responsibility to make them safe. Most companies take this responsibility … Continue reading → (Source: FDA Voice)
Source: FDA Voice - January 23, 2016 Category: American Health Source Type: blogs
FDA Invites Patient Organizations to Take a Place at the Podium
By: Theresa M. Mullin, Ph.D. Sometimes, the most valuable thing we can do as regulators at FDA is simply to listen. I’m reminded of that each time we hold a public meeting as part of the Patient-Focused Drug Development (PFDD) … Continue reading → (Source: FDA Voice)
Source: FDA Voice - January 23, 2016 Category: American Health Source Type: blogs
FDA 2015: A Look Back (and Ahead) – Part 1: Medical Product Innovation
By: Stephen M. Ostroff, M.D. As the year draws to a close, I want to reflect on FDA’s many accomplishments in these previous 12 months, the last nine of which it has been my pleasure to serve as Acting Commissioner. … Continue reading → (Source: FDA Voice)
Source: FDA Voice - January 23, 2016 Category: American Health Source Type: blogs
2015: Another Strong Year for Patients in Need of New Drug Therapies
By: John K. Jenkins, M.D. Happy New Year! Looking back at 2015, I’m pleased to report another strong year for FDA approvals of novel new drugs, which offer many patients new treatment options for serious and life-threatening conditions. In 2015, … Continue reading → (Source: FDA Voice)
Source: FDA Voice - January 23, 2016 Category: American Health Source Type: blogs
FDA 2015: A Look Back (and Ahead) – Part 2: Medical Product Safety and Oversight
By: Stephen M. Ostroff, M.D. In my first look back on FDA’s 2015 accomplishments, I focused on our achievements in medical product innovation and our constant drive to make safe, effective and innovative products available. Because FDA’s responsibility covers the … Continue reading → (Source: FDA Voice)
Source: FDA Voice - January 23, 2016 Category: American Health Source Type: blogs
