miércoles, 11 de octubre de 2017

FDA Patient Network Newsletter - Wednesday October 11, 2017

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Implantable device to treat moderate to severe central sleep apnea approved
On October 6, 2017, FDA approved a new treatment option for patients who have been diagnosed with moderate to severe central sleep apnea. The Remedē System is an implantable device that stimulates a nerve located in the chest that is responsible for sending signals to the diaphragm to stimulate breathing. More information

A1 Slim by Kiriko: Recall - Undeclared Drug Ingredients
Kirikois voluntarily recalling all lots of A1 Slim 30 capsules bottle to the consumer level. FDA laboratory analysis has found the A1 Slim product to be tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine. These undeclared ingredients make this product an unapproved new drug for which safety and efficacy have not been established; therefore, subject to recall. More information

Expanded Access: FDA Describes Efforts to Ease Application Process, by: Scott Gottlieb, M.D., Commissioner FDA
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 also offer expanded access programs that provide investigational drugs and devices to patients with serious conditions (generally prior to product approval), when there is no therapeutic alternative. Continue reading this FDA VoiceBlog or more information about expanded access.

FDA’s Adverse Event Reporting System (FAERS) and new search tool
The FDA’s Adverse Event Reporting System (FAERS) is a database that contains adverse event reports, medication error reports and product quality complaints resulting in adverse events that are submitted to the FDA. The database is used as a surveillance tool to help the agency look for new safety concerns that might be related to a marketed product. It is also used to evaluate a manufacturer's compliance with reporting regulations and responding to outside requests for information. More information

FDA’s continued assistance following the natural disaster in Puerto Rico
FDA continues extensive efforts to provide direct assistance to the residents of Puerto Rico following Hurricanes Irma and Maria, and is taking new steps to mitigate the impact of these twin disasters on the island’s vibrant medical product manufacturing sector. Our top priority is the people of Puerto Rico. 
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.

FDA awards 15 grants for clinical trials to stimulate product development for rare diseases
On October 6, 2017 announced that it has awarded 15 new clinical trial research grants totaling more than $22 million over the next four years to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry across the country. More information

FDA awards six grants for natural history studies in rare diseases
FDA awarded six new research grants for natural history studies in rare diseases. The aim of the research is to inform medical product development by better understanding how specific rare diseases progress over time. One potential application of these studies is the opportunity to eventually use natural history models to augment the need for placebo arms in studies of drugs that target very rare disease, where trial recruitment can be challenging. More information

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

Three Years Later, What is the Impact of the Gluten-Free Labeling Standard?
People with celiac disease, an inflammatory disorder of the small intestine, could get verysick if they 
eat gluten, a mixture of proteins that occur naturally in grains and are found in many foods, including breads, cakes, cereals and p astas. To give these consumers confidence that foods voluntarily labeled “gluten-free” meet a standard established and enforced by the FDA, the agency issued a rule in 2013 t hat defines the characteristics a food has to have to bear such a claim. More information

Safe Food Handling: What You Need to Know
The food supply in the United States is among the safest in the world. However, when certain disease-causing bacteria or pathogens contaminate food, they can cause food-borne illness, often called “food poisoning.” The Federal government estimates that there are about 48 million cases of food-borne illness annually – the equivalent of sickening 1 in 6 Americans each year. And each year, these illnesses result in an estimated 128,000 hospitalizations and 3,000 deaths. More information
Do Not Use Infant Sleep Positioners Due to the Risk of Suffocation
FDA s reminding parents and caregivers not to put babies in sleep positioners. These products—sometimes also called “nests” or “anti-roll” products—can cause suffocation (a struggle to breathe) that can lead to death. More information


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