FDA and NIH Release Final Template for Clinical Trial Protocols
By: Peter Marks, M.D., Ph.D. A little more than a year ago, FDA and NIH announced the availability of a draft template for investigators to use when organizing clinical trial protocols, which are essentially roadmaps for conducting a clinical trial. Today, … Continue reading → (Source: FDA Voice)
Source: FDA Voice - May 2, 2017 Category: American Health Source Type: blogs
Working to Raise Awareness and Reduce Health Disparities
By: Jonca Bull, M.D. April is National Minority Health Month and this year’s theme is “Bridging Health Equity Across Communities.” FDA’s Office of Minority Health (OMH) is committed to the HHS mission of advancing health equity, and our office works … Continue reading → (Source: FDA Voice)
Source: FDA Voice - April 28, 2017 Category: American Health Source Type: blogs
FDA Takes Action Against Fraudulent Cancer Products
By: Donald D. Ashley, J.D., and Douglas Stearn, J.D. A cancer diagnosis often provokes a sense of desperation. Unfortunately, rogue operations exploiting those fears peddle untested and potentially dangerous products, particularly on the internet. FDA responds in two ways: with … Continue reading → (Source: FDA Voice)
Source: FDA Voice - April 25, 2017 Category: American Health Source Type: blogs
Improving the Safety of Imported Foods Through Partnerships
By: Susan Mayne, Ph.D., Camille Brewer, M.S., R.D., and Donald Prater, D.V.M. At FDA, we recognize that the partnerships we build with other nations are key to our success in giving American consumers confidence in the safety of the foods … Continue reading → (Source: FDA Voice)
Source: FDA Voice - April 20, 2017 Category: American Health Source Type: blogs
Redefining the Term “Healthy” on Food Packages – Public Process Plays a Crucial Role
By: Susan Mayne, Ph.D., and Douglas Balentine, Ph.D. When you see the word “healthy” used on a food package, what does that mean to you? It’s FDA’s job to make sure that terms like “healthy,” which many people rely on … Continue reading → (Source: FDA Voice)
Source: FDA Voice - April 20, 2017 Category: American Health Source Type: blogs
America ’s Got Talent – Regulatory Science Style
By: Stephen Ostroff, M.D. Veni Vidi Vici. It translates into English as “I came, I saw, I conquered.” It also happens to be the name chosen by one of the winners of the recently held America’s Got Regulatory Science Talent … Continue reading → (Source: FDA Voice)
Source: FDA Voice - April 14, 2017 Category: American Health Source Type: blogs
A Shocking “Exercize”
By: Suzanne Junod, Ph.D., and John Swann, Ph.D. In this second installment of FDA’s new history video series, the FDA’s historians venture into the “vault” to explore the Relaxacizor, originally sold in beauty salons as a device that stimulated and … Continue reading → (Source: FDA Voice)
Source: FDA Voice - April 11, 2017 Category: American Health Source Type: blogs
PRISM Identifies Vaccine Safety Issues
By: Azadeh Shoaibi, Ph.D., M.H.S. The word “prism” might make you think of a triangular piece of glass that separates white light into a rainbow of colors. But at FDA, it means a powerful, computer-based system that separates critical bits … Continue reading → (Source: FDA Voice)
Source: FDA Voice - April 11, 2017 Category: American Health Source Type: blogs
‘Organs-on-Chips’ Technology: FDA Testing Groundbreaking Science
By: Suzanne Fitzpatrick, Ph.D. There are many things you might envision putting on a chip. It’s unlikely that a human organ is one of them. But creating human organ systems in miniature on micro-engineered chips about the size of a … Continue reading → (Source: FDA Voice)
Source: FDA Voice - April 11, 2017 Category: American Health Source Type: blogs
FDA: Helping Small Businesses Get Big Results
By: Brenda Stodart, Pharm.D., and Renu Lal, Pharm. D. It is well known that small business is vital to the success of the American economy. Less known, though, is how instrumental it has been to the growth and innovation in … Continue reading → (Source: FDA Voice)
Source: FDA Voice - March 30, 2017 Category: American Health Source Type: blogs
FDA in India – Championing a Culture of Quality
By: Mary Lou Valdez One of FDA’s most strategic outposts is in India, the seventh largest supplier of food and second largest supplier of pharmaceuticals and biologics to the United States. The agency’s office, located in the capital, New Delhi, … Continue reading → (Source: FDA Voice)
Source: FDA Voice - March 28, 2017 Category: American Health Source Type: blogs
This is Not a Test: RMAT Designation Goes Live
By: Peter Marks, M.D., Ph.D. The field of regenerative medicine encompasses a wide scope of innovative products including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and certain combination products using such therapies. Examples include genetically-modified cellular … Continue reading → (Source: FDA Voice)
Source: FDA Voice - March 21, 2017 Category: American Health Source Type: blogs
Opening the FDA ’s History Vault
By: Suzanne Junod, Ph.D., and John Swann, Ph.D. Welcome to the FDA’s History Vault, which contains more than 10,000 artifacts that provide a journey through American history and document the critical role played by one of the nation’s oldest public … Continue reading → (Source: FDA Voice)
Source: FDA Voice - March 2, 2017 Category: American Health Source Type: blogs
FDA ’s Commitment to Women’s Heart Health Research
By: Marsha B. Henderson, MCRP FDA research has been especially important in helping FDA better understand cardiovascular diseases in women and the effects of drugs on women’s heart health. Knowing that heart disease is the leading cause of death for … Continue reading → (Source: FDA Voice)
Source: FDA Voice - March 2, 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 - February 25, 2017 Category: American Health Source Type: blogs
