Medical Device Development Tools: Helping to Speed Medical Device Evaluation and Approval
By: Hilda F. Scharen, M. Sc., Capt. USPHS, and Jeffrey Shuren, M.D., J.D. FDA relies on sound science in its decision-making, which provides medical device innovators with a strong base for their product development. Part of good science is relying … Continue reading → (Source: FDA Voice)
Source: FDA Voice - October 24, 2017 Category: American Health Source Type: blogs
FDA Taking New Steps to Better Inform Physicians about Biosimilars Through Education about these Potentially Cost-Saving Options
By: Scott Gottlieb, M.D., and Leah Christl, Ph.D. The cost of prescription drugs is an ongoing concern, however, a growing market for potentially lower-cost biological products called biosimilars can offer more competition and options for patients. Biosimilars can potentially reduce … Continue reading → (Source: FDA Voice)
Source: FDA Voice - October 24, 2017 Category: American Health Source Type: blogs
Generic Drug User Fees Reauthorization: A Victory for Public Health
By: Kathleen Uhl, M.D., and Michael Kopcha, Ph.D., R.Ph. We marked an important milestone in the U.S. generic drug program on Oct. 1, 2017 – the start of the first reauthorization of the Generic Drug User Fee Amendments (GDUFA). These … Continue reading → (Source: FDA Voice)
Source: FDA Voice - October 17, 2017 Category: American Health Source Type: blogs
How FDA ‘Triers’ and Food Sampling Have Prevented Tragedy
By: Suzanne Junod, Ph.D. Throughout history, one of the most important tools used by FDA inspectors to protect the food supply is also one of the simplest – a trier – which allows an inspector to collect a representative sample … Continue reading → (Source: FDA Voice)
Source: FDA Voice - October 12, 2017 Category: American Health Source Type: blogs
Expanded Access: FDA Describes Efforts to Ease Application Process
By: Scott Gottlieb, M.D. FDA has a long history of supporting patient access to investigational new treatments. This includes working with drug and device companies through the clinical trial process that may lead to FDA approval of the treatment. We … Continue reading → (Source: FDA Voice)
Source: FDA Voice - October 3, 2017 Category: American Health Source Type: blogs
Reducing the Hurdles for Complex Generic Drug Development
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 … Continue reading → (Source: FDA Voice)
Source: FDA Voice - October 2, 2017 Category: American Health Source Type: blogs
FDA Takes Important Steps to Stem the Tide of Opioid Misuse and Abuse
By Scott Gottlieb, M.D. America is awash in immediate-release (IR) opioids. About 90 percent of all opioid pain medications prescribed – or 160 million prescriptions a year – are for IR formulations like hydrocodone and acetaminophen or oxycodone and acetaminophen … Continue reading → (Source: FDA Voice)
Source: FDA Voice - September 28, 2017 Category: American Health Source Type: blogs
Making Advances Against Sickle Cell Disease
By: Patricia Oneal, M.D., and Rosanna Setse, M.D., M.P.H., Ph.D. The medical definition of sickle cell disease – a group of inherited red blood cell disorders caused by abnormal hemoglobin, called hemoglobin S or sickle hemoglobin, in red blood cells … Continue reading → (Source: FDA Voice)
Source: FDA Voice - September 27, 2017 Category: American Health Source Type: blogs
How Patient Preferences Contribute to Regulatory Decisions for Medical Devices
By: Jeffrey Shuren, M.D., J.D., Anindita Saha and Martin Ho, M.S. Since we launched our Patient Preference Initiative as part of our medical device regulatory decision-making process in September 2013, we’ve seen increasing evidence of the benefits of soliciting patient … Continue reading → (Source: FDA Voice)
Source: FDA Voice - September 25, 2017 Category: American Health Source Type: blogs
Making the Case for Using Whole Genome Sequencing to Fight Foodborne Illness Globally
By: Steven Musser and Eric L. Stevens FDA is laying the foundation for the use of whole genome sequencing (WGS) to protect consumers from foodborne illness in countries all over the world. We recently traveled to Geneva to join a … Continue reading → (Source: FDA Voice)
Source: FDA Voice - September 14, 2017 Category: American Health Source Type: blogs
FDA is Advancing the Goals of the Orphan Drug Act
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 … Continue reading → (Source: FDA Voice)
Source: FDA Voice - September 12, 2017 Category: American Health Source Type: blogs
“Continuous Manufacturing” – Common Guiding Principles Can Help Ensure Progress
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 … Continue reading → (Source: FDA Voice)
Source: FDA Voice - September 11, 2017 Category: American Health Source Type: blogs
FDA ’s plan to engage the public in the agency’s new effort to strengthen and modernize FDA’s regulatory framework
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 … Continue reading → (Source: FDA Voice)
Source: FDA Voice - September 7, 2017 Category: American Health Source Type: blogs
Tobacco Product Master Files: What Are They and How Could They Benefit You?
By: Mitch Zeller, J.D. In a bid to help streamline and simplify the tobacco product application process and potentially reduce the associated costs, FDA is encouraging the creation and use of tobacco product master files (TPMFs). TPMFs are voluntary submissions … Continue reading → (Source: FDA Voice)
Source: FDA Voice - September 6, 2017 Category: American Health Source Type: blogs
Interoperability: FDA ’s Final Guidance on Smart, Safe, Medical Device Interactions
By: Bakul Patel, M.S., M.B.A. Imagine an intensive care unit for newborns. An interface on a device called a pulse oximeter is sending data on changes in the newborns’ blood oxygen level to a hospital computer system that simultaneously gathers … Continue reading → (Source: FDA Voice)
Source: FDA Voice - September 5, 2017 Category: American Health Source Type: blogs
