Predicting Stem Cell Activity to Ensure Safe and Effective Therapies
By: Steven R. Bauer, Ph.D. We can admire an individualist for being independent and self-directed. But these traits can be disruptive and troublesome when they’re shared by cells called mesenchymal stem cells (MSCs). When these cells (also called human multipotent … Continue reading → (Source: FDA Voice)
Source: FDA Voice - March 8, 2018 Category: American Health Source Type: blogs
Brain Implant for Some Blind People Shows Benefits of FDA ’s Breakthrough Device Program
By: Malvina Eydelman, M.D. FDA’s Breakthrough Devices Program, established in late 2016 under the 21st Century Cures Act, is beginning to show important results for patients. Consider Second Sight Medical Products Inc.’s implant, the Orion, one of the products which … Continue reading → (Source: FDA Voice)
Source: FDA Voice - February 27, 2018 Category: American Health Source Type: blogs
Taking New Steps to Meet the Challenges of Rare Diseases — FDA Marks the 11th Rare Disease Day
By: Scott Gottlieb, M.D. Today 30 million people in the United States – or one out of every 10 Americans – lives with at least one of more than 7,000 rare diseases. These conditions include rare cancers to inherited metabolic … Continue reading → (Source: FDA Voice)
Source: FDA Voice - February 27, 2018 Category: American Health Source Type: blogs
2017 Was Another Record-Setting Year for Generic Drugs
By: Kathleen “Cook” Uhl, M.D. In 2017, FDA’s Center for Drug Evaluation and Research’s generic drug program marked several major accomplishments on behalf of the American people. Our Office of Generic Drugs (OGD) marked another record-setting year for generic approvals … Continue reading → (Source: FDA Voice)
Source: FDA Voice - February 8, 2018 Category: American Health Source Type: blogs
The One-Year Anniversary of the Oncology Center of Excellence
By: Richard Pazdur, M.D. One year ago, Jan. 19, 2017, FDA officially launched the Oncology Center of Excellence to leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics and devices (including diagnostics). In doing so, … Continue reading → (Source: FDA Voice)
Source: FDA Voice - January 19, 2018 Category: American Health Source Type: blogs
FDA to Expedite Release of Recall Information
By: Douglas Stearn, J.D. When FDA identifies that a product it regulates violates the law, it protects the public by working with the manufacturer and distributors to facilitate the product’s recall (i.e., removal from the marketplace or product correction). Among … Continue reading → (Source: FDA Voice)
Source: FDA Voice - January 18, 2018 Category: American Health Source Type: blogs
Charting Our Course for 2018-2020
By: Jeff Shuren, M.D., J.D. Since 2012, we at the Center for Devices and Radiological Health have set as our North Star the vision of patients in the U.S. having access to high-quality, safe, and effective medical devices of public … Continue reading → (Source: FDA Voice)
Source: FDA Voice - January 18, 2018 Category: American Health Source Type: blogs
Many “Firsts” for CDER’s 2017 Drug Approvals Reflect Innovation and Enhanced Patient Care
By: Janet Woodcock, M.D. In 2017, FDA’s Center for Drug Evaluation and Research (CDER) approved many new drugs never before marketed in the United States, known as “novel” drugs, to help improve people’s health. Novel drugs often represent innovative therapies … Continue reading → (Source: FDA Voice)
Source: FDA Voice - January 10, 2018 Category: American Health Source Type: blogs
Reflections on a Landmark Year for Medical Product Innovation and Public Health Advances and Looking Ahead to Policy in 2018
By: Scott Gottlieb, M.D. As we look ahead to 2018, I’d like to take a moment to reflect on an inspiring year of advances in both medicine and public health for FDA — from groundbreaking medical products brought to market … Continue reading → (Source: FDA Voice)
Source: FDA Voice - January 9, 2018 Category: American Health Source Type: blogs
You Spoke, FDA Listened: New Patient Engagement Collaborative, Call for Nominations
By: Nina L. Hunter, Ph.D., and Rachel E. Sherman, M.D, M.P.H. The FDA is committed to collaborating with patients, caregivers, and advocates, as well as incorporating the various perspectives from these groups into the FDA’s regulatory decision-making processes. And we … Continue reading → (Source: FDA Voice)
Source: FDA Voice - December 20, 2017 Category: American Health Source Type: blogs
New Steps to Facilitate Beneficial Medical Device Innovation
By: Scott Gottlieb, M.D. and Jeffrey Shuren, M.D., J.D. In recent days, the Food and Drug Administration (FDA) has committed to several new policies that will modernize the agency’s approach to regulation in the medical device system. For instance, we … Continue reading → (Source: FDA Voice)
Source: FDA Voice - December 14, 2017 Category: American Health Source Type: blogs
Looking ahead: Some of FDA ’s major policy goals for 2018
By: Scott Gottlieb, M.D. Twice a year the federal government publishes the “Unified Agenda of Federal Regulatory and Deregulatory Actions” (Unified Agenda), which provides the American public with insight into regulations under development or review throughout the federal government. For … Continue reading → (Source: FDA Voice)
Source: FDA Voice - December 14, 2017 Category: American Health Source Type: blogs
Treating Infections – FDA is Forging a More Efficient Path to Help Healthcare Providers Treat their Patients
By: Edward M. Cox, M.D., M.P.H. When a patient has an infection, healthcare providers often order a test to help them select a drug that is likely to work against that infection. This testing is performed by laboratories and is … Continue reading → (Source: FDA Voice)
Source: FDA Voice - December 14, 2017 Category: American Health Source Type: blogs
Bringing Early Feasibility Studies for Medical Devices Back to the United States
By: Maureen L. Dreher, Ph.D., Andrew Farb, M.D., and Owen Faris, Ph.D. Ten years ago, when medical device manufacturers wanted to gain early clinical experience with their new devices they often went overseas to conduct first-in-human or small clinical studies. … Continue reading → (Source: FDA Voice)
Source: FDA Voice - December 12, 2017 Category: American Health Source Type: blogs
Advancing Policies to Promote Safe, Effective MedTech Innovation
By: Scott Gottlieb, M.D. Advanced technologies, biomaterials and digital tools are offering us fundamentally better ways to develop new medical devices to advance human health. To build on these innovations and ensure patients have access to safe and effective advances … Continue reading → (Source: FDA Voice)
Source: FDA Voice - December 12, 2017 Category: American Health Source Type: blogs
