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blogs.fda.gov

 •  October 2

By: Scott Gottlieb, M.D. Earlier this year, I announced our Drug Competition Action Plan to advance new policies aimed at bringing more competition to the drug market. My goal was to improve access consumers have to the medicines that they need. I consider access to medicine a matter of public health. If consumers are priced out of the drugs they...

blogs.fda.gov

 •  September 12

By: Scott Gottlieb, M.D. Three months ago, I committed to fully eliminate a backlog of about 200 orphan drug designation requests that were pending review with FDA, and to implement policies that would require FDA to respond to all new designation requests within 90 days of receiving them. Moreover, the agency pledged to never allow a backlog of...

blogs.fda.gov

 •  September 4

By: Pamela E. Scott, Ph.D. When women are pregnant they take care to eat right and refrain from smoking and drinking alcoholic beverages. But what to do about prescription drugs is a more complicated topic. There are very few prescription medications that have been specifically approved for use during pregnancy. And yet, doctors in clinical...

blogs.fda.gov

 •  August 9

By: Theresa M. Mullin, Ph.D. Increasingly, drug development is a global endeavor. It requires international collaboration to ensure that consistent standards are adopted and adhered to by all drug makers and regulatory authorities, regardless of country of origin or destination. FDA’s Theresa Mullin (center) and the FDA delegation engaging in a...

blogs.fda.gov

 •  July 24

By: Richard A. Moscicki, M.D. Patients with serious or immediately life-threatening diseases or conditions who have no comparable or satisfactory alternative therapy and who seek access to potentially life-saving investigational drugs will have another option to guide them through the process – thanks to the launch today of a new online tool called...

blogs.fda.gov

 •  July 12

By Leslie Ball, M.D., Letitia Robinson, Ph.D., R.N, and Elizabeth Wiley, M.D., J.D., M.P.H. After more than 16 hours of travel, we touch down in Mumbai late in the evening and are greeted by a wave of heat and humidity as we exit the airport terminal. As we drive from the airport to the hotel, the vast Mumbai skyline is striking. India is home to...

blogs.fda.gov

 •  June 21

By: Scott Gottlieb, M.D. Too many patients are being priced out of the medicines they need. While FDA doesn’t have a direct role in drug pricing, we can take steps to help address this problem by facilitating increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines. Over the last decade alone,...

blogs.fda.gov

 •  February 14

By: Christopher Hickey, Ph.D. Americans benefit greatly from medical products produced by other countries. Approximately 40 percent of finished drugs in the United States come from overseas, as well as more than 50 percent of all medical devices. About 80 percent of the manufacturers of active pharmaceutical ingredients are located outside the...

blogs.fda.gov

 •  February 14

By: Carolyn A. Wilson, Ph.D. You might only think of FDA as a regulatory agency that oversees medical and food products. But FDA scientists, including those in the Center for Biologics Evaluation and Research (CBER), also perform research. In this first of two blog posts, I will describe how regulatory science, as it is called, helps to turn...

blogs.fda.gov

 •  February 14

By: Lynne Yao, M.D. We all know that children are not just small adults. Many changes occur in children as they grow and develop that can affect how a drug works. In fact, some drugs that work in adults may not work at all in children. There may be different safety concerns compared to when they are used by adults, or they may need to be given in a...