On-Farm Readiness Reviews Support Farmers as They Safeguard Produce
By: Scott Gottlieb, M.D., and Stephen Ostroff, M.D. We know how important it is to get produce safety right. Taking steps to prevent contamination of produce is the primary purpose of the Food Safety Modernization Act’s (FSMA) Produce Safety Rule. … Continue reading → (Source: FDA Voice)
Source: FDA Voice - September 11, 2018 Category: American Health Source Type: blogs
New Program with Payors Aims to Accelerate Patient Access to Medical Devices
By: Scott Gottlieb, M.D. Advancing the public health means helping to make sure patients have access to safe, effective medical products. Access is a matter of public health. And our commitments to patients don’t stop at the time of a … Continue reading → (Source: FDA Voice)
Source: FDA Voice - September 5, 2018 Category: American Health Source Type: blogs
FDA ’s Comprehensive Effort to Advance New Innovations: Initiatives to Modernize for Innovation
By: Scott Gottlieb, M.D. Our longstanding goal for medical care is to ensure that the right drug or device is delivered to the right patient at the right time. This vision is increasingly possible with the innovative products that are … Continue reading → (Source: FDA Voice)
Source: FDA Voice - August 29, 2018 Category: American Health Source Type: blogs
FDA Advances Efficient Approaches to Designing and Conducting Cancer Clinical Trials
By: Richard Pazdur, M.D. Over the past decade, advances in understanding of cancer biology have led to the development of targeted treatments that are more effective than the chemotherapies of the past century. These therapies are demonstrating response rates large … Continue reading → (Source: FDA Voice)
Source: FDA Voice - August 15, 2018 Category: American Health Source Type: blogs
Advancing Tobacco Regulation to Protect Children and Families: Updates and New Initiatives from the FDA on the Anniversary of the Tobacco Control Act and FDA ’s Comprehensive Plan for Nicotine
By: Scott Gottlieb, M.D., and Mitch Zeller, J.D. This summer marks nine years since the Family Smoking Prevention and Tobacco Control Act (TCA) was signed into law, and one year since we announced the FDA’s Comprehensive Plan for Tobacco and … Continue reading → (Source: FDA Voice)
Source: FDA Voice - August 3, 2018 Category: American Health Source Type: blogs
FDA Announces Two Initiatives to Modernize Drug Quality Programs
By: Janet Woodcock, M.D., and Michael Kopcha, Ph.D., R.Ph. Patients expect and deserve high-quality drugs – this means consistently safe and effective medicines, free of defects and contamination. To satisfy these important expectations, the FDA strives to make sure that … Continue reading → (Source: FDA Voice)
Source: FDA Voice - July 26, 2018 Category: American Health Source Type: blogs
Protecting and Promoting Public Health: Advancing the FDA ’s Medical Countermeasures Mission
By Anna Abram The U.S. Food and Drug Administration’s wide-ranging public health responsibilities include the vital role we play on the frontlines of national security by facilitating the development and availability of safe and effective medical countermeasures. These are the … Continue reading → (Source: FDA Voice)
Source: FDA Voice - July 16, 2018 Category: American Health Source Type: blogs
FDA Budget Matters: Infrastructure to Support Robust Generic Drug Competition
By: Scott Gottlieb, M.D. The FDA launched its Drug Competition Action Plan more than a year ago, with the aim of advancing policies that would promote robust generic drug entry as a way to foster competition and lower drug prices. … Continue reading → (Source: FDA Voice)
Source: FDA Voice - July 13, 2018 Category: American Health Source Type: blogs
FDA Budget Matters: Investing in Advanced Domestic Manufacturing
By: Scott Gottlieb, M.D. There’s new technology that can improve drug quality, address shortages of medicines, lower drug costs, and bring pharmaceutical manufacturing back to the United States. At the FDA, we’re focused on propelling these innovations, collectively referred to … Continue reading → (Source: FDA Voice)
Source: FDA Voice - July 13, 2018 Category: American Health Source Type: blogs
FDA Budget Matters: A Cross-Cutting Data Enterprise for Real World Evidence
By: Scott Gottlieb, M.D. Over time, as our experience with new medical products expands, our knowledge about how best to maximize their benefits and minimize any potential risks, sharpens with each data point we gather. Every clinical use of a … Continue reading → (Source: FDA Voice)
Source: FDA Voice - July 10, 2018 Category: American Health Source Type: blogs
The American Chamber of Horrors
By: Vanessa Burrows, Ph.D., Suzanne Junod, Ph.D., and John Swann, Ph.D. In the early 20th century, Americans were inundated with ineffective and dangerous drugs, as well as adulterated and deceptively packaged foods. A cosmetic eyelash and eyebrow dye called Lash … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 29, 2018 Category: American Health Source Type: blogs
Budget Matters: Infrastructure to Support Robust Generic Drug Competition
By: Scott Gottlieb, M.D. The FDA launched its Drug Competition Action Plan more than a year ago, with the aim of advancing policies that would promote robust generic drug entry as a way to foster competition and lower drug prices. … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 19, 2018 Category: American Health Source Type: blogs
Report Spotlights Achievements of FDA-Mexico Produce Safety Partnership
By: Stephen M. Ostroff, M.D. The United States and Mexico are major trading partners in fresh produce. Each year, billions of dollars of fruits and vegetables move across the border. These include Mexican tomatoes, avocados, chilies, berries, cucumbers, lemons, and … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 15, 2018 Category: American Health Source Type: blogs
FDA ’s New Efforts to Advance Biotechnology Innovation
By: Scott Gottlieb, M.D., and Anna Abram Scientific advances in biotechnology, such as genome editing and synthetic biology, hold enormous potential to improve human and animal health, animal welfare, and food security. And researchers and companies based in the United … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 6, 2018 Category: American Health Source Type: blogs
FDA Proposes Process Modernization to Support New Drug Development
By: Janet Woodcock, M.D. The staff of the FDA’s Center for Drug Evaluation and Research (CDER) always tries to utilize cutting-edge science and up-to-date process management, befitting our stature as the global “gold standard” in drug regulation. Maintaining that standard … Continue reading → (Source: FDA Voice)
Source: FDA Voice - June 4, 2018 Category: American Health Source Type: blogs
