FDA-Required Studies of Approved Drugs Make a Big Difference for Public Health
By: Peter Stein. M.D. Drugs are approved by FDA based upon substantial evidence from clinical trials that the medicine will be both effective and safe for use if prescribed according to its labeling. However, there may be issues that need … Continue reading → (Source: FDA Voice)
Source: FDA Voice - December 7, 2017 Category: American Health Source Type: blogs
FDA Launches Predictive Toxicology Roadmap to Enable Advances in Toxicity Testing
By: RADM Denise M. Hinton and Suzanne Fitzpatrick, Ph.D. Toxicology testing plays a pivotal role in ensuring the safety of FDA-regulated products. During the development and evaluation of almost all FDA-regulated products, testing is performed on people or animals to … Continue reading → (Source: FDA Voice)
Source: FDA Voice - December 6, 2017 Category: American Health Source Type: blogs
Communication, Breaking Down Walls, and a Huge Step Forward for People with Type 1 Diabetes
By: Courtney Lias, Ph.D., and Stayce Beck, Ph.D., M.P.H. At FDA’s Center for Devices and Radiological Health (CDRH) we recognize that medical innovators with a novel technology can get lost in navigating the regulatory landscape if there is no well-worn … Continue reading → (Source: FDA Voice)
Source: FDA Voice - December 5, 2017 Category: American Health Source Type: blogs
PEPFAR: FDA Approves 200th HIV/AIDS Therapy
By: Scott Gottlieb, M.D. Since 1981, when the first case of AIDS was reported in this country, U.S. and foreign governments, scientists, grassroots and global community health organizations, patients, and their families have worked hard to address the impact of … Continue reading → (Source: FDA Voice)
Source: FDA Voice - December 1, 2017 Category: American Health Source Type: blogs
Advancing Medicinal Nicotine Replacement Therapies as New Drugs – A new step in FDA ’s comprehensive approach to tobacco and nicotine
By: Scott Gottlieb, M.D., Janet Woodcock, M.D., Mitchell Zeller, J.D. As the leading cause of preventable disease and death in the United States, tobacco causes more than 480,000 deaths every year. To address this devastation, earlier this year FDA announced … Continue reading → (Source: FDA Voice)
Source: FDA Voice - November 29, 2017 Category: American Health Source Type: blogs
FDA, International Regulators Look at Common Challenges, ‘Innovation’
By: Lou Valdez, M.S., Dara Corrigan, J.D., and Peter Stein, M.D. Regulatory experts from around the world, including FDA, gathered recently to discuss issues such as regenerative medical products, international collaboration to fight antimicrobial resistance (AMR), and developing strategies to … Continue reading → (Source: FDA Voice)
Source: FDA Voice - November 29, 2017 Category: American Health Source Type: blogs
X-rays and Children: FDA Issues Guidance to Minimize Dose
By: Vasum Peiris, M.D., M.P.H. In medicine, knowledge is power and the information and knowledge gained from medical imaging have transformed the way medicine is practiced in less than a generation. Advances in X-ray imaging have evolved dramatically and span … Continue reading → (Source: FDA Voice)
Source: FDA Voice - November 29, 2017 Category: American Health Source Type: blogs
Talking FSMA in the Land of Cotton and Looking for Middle Ground
By: Stephen Ostroff, M.D. You may not know that in addition to producing cotton for the fabrics that we use every day, cotton farmers and ginners produce food. After being separated from fibers in a process called ginning, cotton seeds … Continue reading → (Source: FDA Voice)
Source: FDA Voice - November 27, 2017 Category: American Health Source Type: blogs
FDA Takes Steps to Build a Stronger Workforce
By: Scott Gottlieb, M.D. FDA faces challenges related to building and maintaining a diverse, talented, and dedicated professional workforce. The agency’s responsibilities increasingly demand a staff with specialized skills; and our own process sometimes doesn’t fully support our ability to … Continue reading → (Source: FDA Voice)
Source: FDA Voice - November 15, 2017 Category: American Health Source Type: blogs
FDA Awards Funding to Support Pediatric Clinical Trials Research
By: Susan McCune, M.D. Despite many efforts over the past two decades to increase the number of FDA-approved therapies for children, some 60 percent of drugs that are used in children are not approved for pediatric use, and the percentage … Continue reading → (Source: FDA Voice)
Source: FDA Voice - November 9, 2017 Category: American Health Source Type: blogs
FDA Is Making It Easier To Meet Required Extra Safety Measures for Certain FDA-Approved Drugs
By: Theresa Toigo, MBA, RPh For some FDA-approved drugs specific safety steps must be taken before the patient can receive the medication. These measures, which may involve the patient, health care providers and manufacturers, are part of an FDA-required program … Continue reading → (Source: FDA Voice)
Source: FDA Voice - November 8, 2017 Category: American Health Source Type: blogs
“This is Our Watch”: FDA Supports Retailers in Keeping Tobacco Out of Youth’s Hands
By: Mitch Zeller, J.D. Each day in the United States, nearly 2,500 youth under age 18 smoke their first cigarette and more than 400 become daily cigarette smokers. In fact, more teenage boys light up a cigar each day (about … Continue reading → (Source: FDA Voice)
Source: FDA Voice - November 7, 2017 Category: American Health Source Type: blogs
FDA Widens Scope of Navigator – Information Tool for Expanded Access
By: Scott Gottlieb, M.D. FDA is committed to expanding access to safe and effective treatment options for patients with rare, debilitating, and sometimes fatal diseases. These patients face unique medical challenges. Sometimes there isn’t an FDA-approved drug to adequately address … Continue reading → (Source: FDA Voice)
Source: FDA Voice - November 2, 2017 Category: American Health Source Type: blogs
FDA ’s Role in Medical Device Cybersecurity
By: Suzanne Schwartz, M.D., M.B.A. Virtually every aspect of our lives – including our health – has gone digital. Medical devices from insulin pumps to implantable cardiac pacemakers are becoming more interconnected and, like computers and the networks they operate … Continue reading → (Source: FDA Voice)
Source: FDA Voice - October 31, 2017 Category: American Health Source Type: blogs
The Mammography Quality Standards Act – a 25-year Public Health Success Story
By: Helen Barr, M.D. Mammography has been widely used as a screening tool to detect early stage breast cancer since the mid 1960s. As use of the technology expanded it became clear that there were wide variations in the quality … Continue reading → (Source: FDA Voice)
Source: FDA Voice - October 27, 2017 Category: American Health Source Type: blogs
