viernes, 22 de diciembre de 2017

FDA Patient Network Newsletter - December 20, 2017

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FDA approves Admelog, the first short-acting "follow-on" insulin product to treat diabetes
The FDA approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients aged 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. Admelog is the first short-acting insulin approved as a “follow-on” product. More information

FDA approves first drug for Eosinophilic Granulomatosis with Polyangiitis, a rare disease formerly known as the Churg-Strauss Syndrome
The FDA expanded the approved use of Nucala (mepolizumab) to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease that causes vasculitis, an inflammation in the wall of blood vessels of the body. This new indication provides the first FDA-approved therapy specifically to treat EGPA. More information 

Gadolinium-based Contrast Agents (GBCAs): Drug Safety Communication - Retained in Body; New Class Warnings
FDA is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs. Gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and FDA has concluded that the benefit of all approved GBCAs continues to outweigh any potential risks. More information

Marmex Corp Issues Voluntary Nationwide Recall Of Blue Pearl All Natural Male Enhancement Supplement, Due To Undeclared Sildenafil
Orange, CA, Marmex Corp is voluntarily recalling All lots of Blue Pearl All Natural Male Enhancement Supplement, 500mg to the consumer level. FDA analysis has found the products to contain sildenafil. The presence of the undeclared active ingredients renders them unapproved drugs for which safety and efficacy have not been established. More information

FDA warns companies for promoting alternatives to street drugs
The FDA posted a warning letter to the marketers and distributors of Legal Lean Syrup, a drink, and Coco Loko, a “snortable” chocolate powder, for selling unapproved new drugs and misbranded drugs. The warning letter explains how the claims made in the promotional materials for Legal Lean Syrup and Coco Loko demonstrate that the products are intended to be used as alternatives to illicit street drugs and that the products, as labeled and marketed, may pose safety concerns. More information

Physio-Control Inc. is recalling infant/child defibrillation electrodes because the artwork on the pads within the packaging shows incorrect placement instructions for infants. There is no issue with the performance or function of the defibrillation electrodes. However, incorrect placement of the electrodes on an infant may result in failure to deliver an effective shock to an infant in cardiac arrest.  A delay in therapy could result in serious injury and/or death. More information

FDA posts new info about using laparoscopic power morcellators to treat uterine fibroids
Laparoscopic power morcellators are Class II medical devices used during laparoscopic (minimally invasive) surgeries to cut tissue into smaller pieces so the tissue can be removed through a small incision site (typically 2 cm long or less).
These devices are commonly used in gallbladder, kidney, liver, and spleen removal surgery. They are also used in hysterectomy (surgical procedure to remove a women’s uterus) and myomectomy (surgical procedure to remove uterine fibroids which are noncancerous growths in the lining of a women’s uterus). More information

Looking ahead: Some of FDA’s major policy goals for 2018
By: Scott Gottlieb, M.D., Commissioner of the FDA

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 the U.S. Food and Drug Administration (FDA), it gives us an opportunity to outline some of our efforts to modernize our approach to our work and improve our efficiency, while fulfilling our mandate to protect and promote the public health and uphold FDA’s gold standard for regulatory decision-making. While many of FDA’s polices are advanced through guidance documents and other proposals, this annual list of proposed regulations provides one element of our policy agenda.
Patients and consumers across our country depend on us to regulate products in a predictable, efficient, science-based manner. More information

New Step to Facilitate Beneficial Medical Device Innovation
By: Scott Gottlieb, M.D., Commissioner of the FDA

In recent days, the FDA has committed to several new policies that will modernize the agency’s approach to regulation in the medical device system.
For instance, we announced our intention to propose an alternate approach to the traditional 510(k) clearance process, which will involve the use of modern, science-based, consensus standards and FDA-developed performance criteria as the comparator for device review for certain well-understood technologies. FDA currently compares new devices to predicate devices that can in many cases be as much as 40 years old. By modernizing the standards that FDA uses to assess some new devices, it will make it easier to innovate these products, and adopt more up-to-date and rigorous benchmarks for evaluating their safety and effectiveness. 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 takes step to close orphan drug loophole that let drug developers sidestep pediatric studies
The FDA  issued a draft guidance for industry, Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases to provide clarity for industry on orphan drug designation requirements, noting that if a sponsor requests orphan drug designation for a pediatric subpopulation of a common disease, and even if the pediatric subpopulation prevalence is below 200,000.

The agency welcomes public comment on the draft guidance, which is part of the Orphan Drug Modernization Plan announced in June 2017. More information

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.

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 know that patients and other stakeholders agree with the agency’s commitment to improving and increasing patient involvement in FDA matters. In fact, members of the patient and stakeholder communities commented in public feedback on Section 1137, Patient Participation in Medical Product Discussions, of the Food and Drug Administration Safety and Innovation Act (FDASIA). Stakeholders recommended that the FDA create an outside group to provide input on patient engagement across the agency. We are pleased to announce that in response to that feedback and to accelerate the FDA’s efforts in this area, today the FDA published a request for nominations to join the FDA’s Patient Engagement Collaborative (PEC). More information

What Is Gene Therapy? How Does It Work?
The genes in your body’s cells play an important role in your health — indeed, a defective gene or genes can make you sick.
Recognizing this, scientists have been working for decades on ways to modify genes or replace faulty genes with healthy ones to treat, cure or prevent a disease or medical condition. Now this research on gene therapy is finally paying off. Since August 2017, the U.S. Food and Drug Administration has approved three gene therapy products, the first of their kind. More information

Cold and Flu: Prevention, Symptoms, Treatments
Cold and flu viruses are always around. So why do we seem to be especially vulnerable during the fall and winter months?
For the most part, it’s because we spend more time indoors, and the viruses that cause the sniffles, congestion, and body aches of a cold or the flu can spread more easily from person to person. You can fight back by adopting healthy habits and by using medicines and vaccines approved by the FDA.
More information

Drug Discontinuation Voluntarily Reported by Manufacturers During the Past 2 Weeks:

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