California dietary supplement maker, Custompax prohibited from manufacturing
A California dietary supplement manufacturer recently was ordered by a federal court to stop selling its products until the company comes into compliance with the U.S. Food and Drug Administration’s dietary supplement manufacturing regulations and other requirements listed in a consent decree. More information
FDA warns Magellan Diagnostics of significant violations of the law as part of investigation into lead testing issues
On October 23, 2017 FDA issued a warning letter to Magellan Diagnostics Inc. for several violations of federal law, including marketing significantly modified versions of two of its blood lead testing systems without the FDA’s required clearance or approval and failing to submit medical device reports to the FDA after becoming aware of customer complaints involving discrepancies in blood lead test results. More information
CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma approved
FDA approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta, a chimeric antigen receptor (CAR) T cell therapy, is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL). More information
First 7T magnetic resonance imaging device cleared
FDA cleared the first seven tesla (7T) magnetic resonance imaging (MRI) device, more than doubling the static magnetic field strength available for use in the United States. The Magnetom Terra is the first 7T MRI system cleared for clinical use in the United States. The overall image quality of MRI improves with higher magnetic field strength and the added field strength allows for better visualization of smaller structures and subtle pathologies that may improve disease diagnosis.”. More information
New robotically-assisted surgical device cleared for adult patients
FDA cleared the Senhance System, a new robotically-assisted surgical device (RASD) that can help facilitate minimally invasive surgery. “Minimally invasive surgery helps reduce pain, scarring and recovery time after surgery,” said Binita Ashar, M.D., director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health. More information
FDA Statement on Baxter Manufacturing Recovery in Puerto RicoSince Hurricanes Irma and Maria devastated the island of Puerto Rico, the FDA has been working closely with Baxter and other companies to reduce the risk of shortages of critically important drugs and to minimize impact on any existing shortages. In particular, Baxter and the FDA have closely monitored and identified ways to prevent a significant shortfall of production of Baxter’s sodium chloride 0.9% injection bags from its Puerto Rico facility. More information
FDA statement on medical device manufacturing recovery in Puerto Rico
During the weeks since Hurricanes Irma and Maria devastated the infrastructure of Puerto Rico, the U.S. Food and Drug Administration has joined federal and local agencies in the effort to help the people of Puerto Rico recover and begin to rebuild the island. Among the challenges the FDA has addressed is the potential for shortages of critical medical products. The FDA has been monitoring more than 40 drug products and working closely with dozens of pharmaceutical and medical device companies to help these important facilities get back online; enabling employees to return to work and manufacturers to ramp up production of medical products used by all Americans. More information
New steps to advance medical device innovation and help patients gain faster access to beneficial technologies
Enabling patients and providers to have efficient access to new and innovative medical products that meet the FDA’s gold standard for safety and effectiveness is a core part of our mission. We’re advancing these goals as part of the Medical Innovation Access Plan that I announced earlier this year. While we’ve unveiled parts of that plan already, we’ll be releasing its full detail shortly. As one part of that effort, we’re announcing some additional steps we’re taking right now to promote beneficial medical device innovation. More information
Most FDA meetings are free to the public and do not require the public to register. Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee. Other types of meetings listed may require prior registration and fees. View FDA Patient Network Calendar of FDA Sponsored Public Meetings for a list of meetings and workshops that may be of interest to patients and caregivers.
FDA rules have great impact on the nation’s health, these rules are formed with the public's help. By law, anyone can participate in the rule-making process by commenting in writing.
View FDA Patient Network Opportunity to Comment on Current Draft Guidance page, for a list of current draft guidances and other topics of interest for patients and caregivers.
View FDA Patient Network Opportunity to Comment on Current Draft Guidance page, for a list of current draft guidances and other topics of interest for patients and caregivers.
National Prescription Drug Take Back Day - October 28, 2017
Medicines play an important role in treating many conditions and diseases and when they are no longer needed it is important to dispose of them properly to help reduce harm from accidental exposure or intentional misuse. Below, we list some options and special instructions for you to consider when disposing of expired, unwanted, or unused medicines. More information
Biosimilars
Congress, through the Biologics Price Competition and Innovation Act (BPCI Act) of 2009, created an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-approved biological product. This pathway was established as a way to provide more treatment options, increase access to lifesaving medications, and potentially lower health care costs through competition. More information
Generic Drug User Fees Reauthorization: A Victory for Public Health, by: Kathleen Uhl, M.D. Director, Office of Generic Drugs , and Michael Kopcha, Ph.D., R.Ph., Director, Office of Pharmaceutical Quality
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 fees from industry provide FDA with vital funding that advances the Agency’s regulatory work to review and approve applications for generic drugs. This wasn’t just a milestone for FDA – it was a victory for public health. Increasing consumer access to safe, high-quality, and affordable generic drugs is a top priority at FDA. More information
Medical Device Development Tools
The FDA’s Medical Device Development Tools (MDDT) program is a way for the FDA to qualify tools that medical device sponsors can use in the development and evaluation of medical devices. Qualification means that the FDA has evaluated the tool and concurs with available supporting evidence that the tool produces scientifically-plausible measurements and works as intended within the specified context of use. More information
Medicines play an important role in treating many conditions and diseases and when they are no longer needed it is important to dispose of them properly to help reduce harm from accidental exposure or intentional misuse. Below, we list some options and special instructions for you to consider when disposing of expired, unwanted, or unused medicines. More information
Biosimilars
Congress, through the Biologics Price Competition and Innovation Act (BPCI Act) of 2009, created an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-approved biological product. This pathway was established as a way to provide more treatment options, increase access to lifesaving medications, and potentially lower health care costs through competition. More information
Generic Drug User Fees Reauthorization: A Victory for Public Health, by: Kathleen Uhl, M.D. Director, Office of Generic Drugs , and Michael Kopcha, Ph.D., R.Ph., Director, Office of Pharmaceutical Quality
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 fees from industry provide FDA with vital funding that advances the Agency’s regulatory work to review and approve applications for generic drugs. This wasn’t just a milestone for FDA – it was a victory for public health. Increasing consumer access to safe, high-quality, and affordable generic drugs is a top priority at FDA. More information
Medical Device Development Tools
The FDA’s Medical Device Development Tools (MDDT) program is a way for the FDA to qualify tools that medical device sponsors can use in the development and evaluation of medical devices. Qualification means that the FDA has evaluated the tool and concurs with available supporting evidence that the tool produces scientifically-plausible measurements and works as intended within the specified context of use. More information
Drug Discontinuation Voluntarily Reported by Manufacturers During the Past 2 Weeks:
- Metoclopramide Injection, USP 5mg/1 mL
- Sumatriptan (ZECUITY)Iontophoretic Transdermal System
- Midodrine HCL Tablets
FDA knows the major public health consequences that can result from drug shortages. These shortages occur for many reasons including manufacturing and quality problems, delays and discontinuations. When issues are discovered, FDA works closely with the company to address risks involved to prevent harm to patients. FDA also considers the impact a shortage would have on patient care and access and works with the company to restore supplies while also ensuring safety for patients.
More information on drug shortages and discontinuations: Drug Shortage Database andVaccines, Blood and Biologic Shortages
Two public meetings on agricultural biotechnology education and outreach
FDA announced public meetings to be held in Charlotte, North Carolina on November 7, 2017, and in San Francisco, California on November 14, 2017, regarding its Agricultural Biotechnology Education and Outreach Initiative. Congress appropriated $3 million to fund this initiative, which calls upon the FDA to work with USDA to provide education and outreach to the public on agricultural biotechnology and food and animal feed ingredients derived from biotechnology. More information
FDA announced public meetings to be held in Charlotte, North Carolina on November 7, 2017, and in San Francisco, California on November 14, 2017, regarding its Agricultural Biotechnology Education and Outreach Initiative. Congress appropriated $3 million to fund this initiative, which calls upon the FDA to work with USDA to provide education and outreach to the public on agricultural biotechnology and food and animal feed ingredients derived from biotechnology. More information
The Real Cost Campaign
Every day in the U.S., nearly 2,500 youth under age 18 smoke their first cigarette, and more than 1,000 male youth use smokeless tobacco for the first time. In fact, tobacco use is almost always started and established during adolescence because the developing brain is especially vulnerable to nicotine addiction.
After decades of steadily declining rates, youth tobacco use has largely plateaued since 2011 due to sharp increases in e-cigarette and hookah tobacco use among teens in recent years. Nationwide, more than 2 million teens currently use e-cigarettes. Further, youth who use tobacco today do so despite the efforts that led so many of their peers to remain tobacco-free in the past, making them an even harder group to reach and highlighting a critical need for stronger, more targeted youth tobacco prevention efforts. More information
Every day in the U.S., nearly 2,500 youth under age 18 smoke their first cigarette, and more than 1,000 male youth use smokeless tobacco for the first time. In fact, tobacco use is almost always started and established during adolescence because the developing brain is especially vulnerable to nicotine addiction.
After decades of steadily declining rates, youth tobacco use has largely plateaued since 2011 due to sharp increases in e-cigarette and hookah tobacco use among teens in recent years. Nationwide, more than 2 million teens currently use e-cigarettes. Further, youth who use tobacco today do so despite the efforts that led so many of their peers to remain tobacco-free in the past, making them an even harder group to reach and highlighting a critical need for stronger, more targeted youth tobacco prevention efforts. More information
Halloween Safety: Costumes, Candy, and Colored Contact Lenses
Whether you’re a ghost or zombie, vampire or witch, poor costume choices—including decorative (colored) contact lenses and flammable costumes—and face paint allergies can cause injuries that haunt you long after Halloween. Enjoy a safe and happy Halloween by following these guidelines from FDA, the Consumer Product Safety Commission, and the Centers for Disease Control and Prevention. More information
Biosimilars: More Treatment Choices and Innovation
Biosimilar products provide more treatment options to patients, potentially lowering treatment costs and increasing access to lifesaving medications.
FDA has approved biosimilar products to treat conditions such as cancer, Crohn’s disease and colitis, irritable bowel syndrome, rheumatoid arthritis, psoriasis and more. But what are biosimilars? To answer this question, it helps to first know what biological products (biologics) are. More information
The FDA Patient Network Newsletter is provided to you by the FDA Office of Health and Constituent Affairs. If you have questions about the newsletter, email us at PatientNetwork@FDA.HHS.GOV
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