FDA Voice

FDA Voice
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FDA Voice

 •  September 12

By: Michael Kopcha, Ph.D., R.Ph. Today, a new and exciting technology – continuous manufacturing (CM) – can truly transform the drug manufacturing process so that it is more reliable and efficient. We discussed in a previous blog how CM enables a much faster and more reliable manufacturing process. In some cases, manufacturing that takes a month...

FDA Voice

 •  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...

FDA Voice

 •  September 7

By: Anna Abram We’re at a moment of extraordinary opportunity to improve the public health. New innovations are giving us fundamentally better ways to address disease. Some of the same technology is providing consumers with a broader selection of foods that can improve peoples’ diets, and products that can expand their choices. At the same time,...

FDA Voice

 •  August 31

By: Scott Gottlieb, M.D. Manufacturing of drugs has become increasingly complex and global, requiring us to remodel our oversight of these tasks, to improve FDA’s efficiency and reach. As a step toward achieving these goals, FDA previously announced that we’re restructuring our field activities, to direct our focus and organization around the...

FDA Voice

 •  August 21

By: Peter Marks, M.D., Ph.D., Jeffrey Shuren, M.D., J.D., and Janet Woodcock, M.D. Peter Marks, M.D., Ph.D., Director of FDA’s Center for Biologics Evaluation and Research For decades, user fees paid by the medical products industry have provided critical resources needed to conduct product reviews in a timely fashion and to help ensure the safety...

FDA Voice

 •  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...

FDA Voice

 •  July 31

By: Douglas Stearn The data is in. A new automated system for determining whether FDA-regulated products can enter the United States is allowing us to make decisions faster and more efficiently. Quick admissibility decisions are critical to commerce, especially when perishable products are involved. The new system brings better response times...

FDA Voice

 •  July 20

By: Ilisa Bernstein, Pharm.D., J.D. The U.S. prescription drug supply is among the safest in the world, but it can be challenging to keep it that way. Criminals – both here and abroad – constantly threaten to replace safe, effective, and high-quality prescription medications with counterfeit, stolen, and otherwise substandard products. Roughly 4...

FDA Voice

 •  July 17

By: Scott Gottlieb, M.D. The key to FDA’s public health mission, and its ability to bring innovative new therapies to patients, is the technical, scientific, and clinical expertise of its people. As the products that we’re asked to review become more complex and specialized, so do the technical demands on our workforce. Our staff must remain...

FDA Voice

 •  July 7

By: Scott Gottlieb, M.D. We’re at a point in science where new medical technologies hold out the promise of better treatments for a widening number of vexing conditions. Over the last few decades, science has enabled fundamental advances in our understanding of the genetic and protein bases of human disease. These developments are already being...