Addressing Global Challenges through Transatlantic Cooperation
By: Howard Sklamberg, J.D., Lou Valdez, and Donald Prater On a recent trip to Brussels, our FDA delegation met with many of our European Union (EU) regulatory counterparts and stakeholders to discuss ways to strengthen our shared commitment to product … Continue reading → (Source: FDA Voice)
Source: FDA Voice - July 20, 2016 Category: American Health Source Type: blogs
The Rise in Orphan Drug Designations: Meeting the Growing Demand
By: Gayatri Rao, M.D., J.D. Developing drugs for rare diseases, once considered a rare phenomenon itself, has fast become a mainstay for many companies’ drug development pipelines. This is exciting news for the 30 million Americans with rare diseases and … Continue reading → (Source: FDA Voice)
Source: FDA Voice - July 18, 2016 Category: American Health Source Type: blogs
The United Nations Sustainable Development Goals: Efficient and effective regulatory systems are the tide that raises all boats
By: Mary Lou Valdez, M.S.M., and Kristin Wedding Do you think it’s possible to ensure healthy lives and promote well-being for all people of all ages by 2030? That’s just one of the United Nations 17 Sustainable Development Goals (SDGs), … Continue reading → (Source: FDA Voice)
Source: FDA Voice - July 15, 2016 Category: American Health Source Type: blogs
Charting a Path Forward on Food Safety, Nutrition and Animal Health
By: Stephen Ostroff, M.D., Susan Mayne, Ph.D., and Tracey Forfa, J.D. At FDA, we need to be prepared for the opportunities and challenges of today as well as those of tomorrow, and the FDA Foods and Veterinary Medicine Program’s new … Continue reading → (Source: FDA Voice)
Source: FDA Voice - July 14, 2016 Category: American Health Source Type: blogs
Registration of Food Facilities: A Key Link in the Safety Chain
By: Erwin C. Miller, M.S. The FDA’s mission to protect consumers from unsafe food follows different paths. The seven rules that have been finalized since last fall to implement the 2011 FDA Food Safety Modernization Act (FSMA) will require food … Continue reading → (Source: FDA Voice)
Source: FDA Voice - July 14, 2016 Category: American Health Source Type: blogs
FDA Takes Action against Zika Virus
By: Robert M. Califf, M.D., and Luciana Borio, M.D. Zika virus was first identified in 1947 in Uganda and for decades only sporadic cases and a few outbreaks were recognized in a number of locations, including parts of Africa, Asia, … Continue reading → (Source: FDA Voice)
Source: FDA Voice - July 12, 2016 Category: American Health Source Type: blogs
Leveraging the Power of Collaboration – FDA’s New Oncology Center of Excellence
By: Richard Pazdur, M.D. I am honored to be selected by Commissioner Califf today as the acting director of FDA’s new Oncology Center of Excellence (OCE) in support of the Vice President’s National Cancer Moonshot Initiative. This new center will … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 29, 2016 Category: American Health Source Type: blogs
FDA Advisory Committee Members and ‘Appearance Issues’
By: Michael Ortwerth, Ph.D. FDA relies on its advisory committees as a source of independent scientific and technical expertise and advice on challenging public health issues. Most advisory committee members are appointed as “special government employees” (SGEs). Like regular government … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 29, 2016 Category: American Health Source Type: blogs
Sleuthing, and a Little Help from Consumers, Helps FDA Track Down Bacteria in Flour
By: Stephen Ostroff, M.D., and Kathleen Gensheimer, M.D., M.P.H. When many people buy flour, they empty it into a canister and throw out the bag. But three people at the center of a recent outbreak of foodborne illness didn’t do … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 28, 2016 Category: American Health Source Type: blogs
FDA: A Great Place for Science…and for Scientists on the New Frontier of Regulatory Science
By: Robert M. Califf, M.D. As FDA Commissioner, I’m proud of our agency’s extraordinary commitment to using the best available science to support our mission to protect and promote the health of the American public. This is especially critical today, … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 24, 2016 Category: American Health Source Type: blogs
FDA Celebrates the 40th Anniversary of the Medical Device Amendments
By: Jeffrey Shuren, M.D., J.D. In 1976, Steve Jobs and Steve Wozniak founded Apple and a gallon of gas was $.59. And in another action that has had long term impact, President Ford signed the Medical Device Amendments that closed … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 22, 2016 Category: American Health Source Type: blogs
Important steps toward streamlining access to investigational drugs for patients in need
By: Richard A. Moscicki, M.D. FDA is only too aware that there are many patients who have a serious or life-threatening medical condition for which there is no available FDA-approved therapy. For such patients, one option may be to obtain … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 22, 2016 Category: American Health Source Type: blogs
CBER Laboratories in the Life Sciences-Biodefense Complex
By: Carolyn A. Wilson, Ph.D. Wise management of research programs means more than selecting projects that will yield the most scientific information but also making sure that we are making wise use of the dollars we allot for research. That’s … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 21, 2016 Category: American Health Source Type: blogs
A Tale of 3 Countries: Applying FSMA Standards Globally
By: Stephen Ostroff, M.D., and Camille Brewer, M.S., R.D. Over the past two months, we have been part of FDA delegations visiting three very diverse countries—Canada, China and Mexico—to discuss food safety. As we are doing in the United States … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 15, 2016 Category: American Health Source Type: blogs
Be A Champion for Clinical Trial Diversity
By: Jonca Bull, M.D. The FDA is launching a campaign to encourage minorities to participate in clinical trials for all medical conditions. The first part of the campaign will be launched on June 19, 2016, World Sickle Cell Day, observed … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 14, 2016 Category: American Health Source Type: blogs
