September 20, 2017
ANNOUNCEMENTS
In Pursuit of Tardive Dyskinesia: The Breakthrough Designation and Approval of Valbenazine
Diseases that are caused by medical treatments and procedures are a particular bane to health care providers. One such example is tardive dyskinesia, a side effect of taking antipsychotic medicines. Tardive dyskinesia is a neurological disorder characterized by repetitive, involuntary movements such as lip smacking or pursing, as well as tongue movements. Tardive dyskinesia significantly impacts the health and quality of life of many people who live with psychiatric illnesses, and the disorder is often irreversible. The FDA approval of valbenazine this year, the first drug to be indicated for tardive dyskinesia, is therefore noteworthy—not only because it addresses an unmet need, but also because of how it was approved. More information
Webinar: An Overview of FDA Resources
On October 17, 2017 at 1pm (EDT), CDER's Office of Communication, Division of Drug Information (DDI) will host a webinar titled: An Overview of FDA Resources. This webinar will provide an orientation to drug information resources on the FDA website. Health care professionals can utilize these resources to respond to questions, and to promote safe use of drug products. Topics will include drug shortages, recalls, adverse events, and safety labeling updates. More information
Crops impacted by Hurricanes Harvey and Irma and FDA’s work with farmers affected by the storms
This is the first time that two category 4 storms have hit the U.S. back-to-back, and the effects have been devastating. At FDA we have a large team working on providing assistance to those affected by these storms, including American farmers who have suffered crop losses. You’ll be hearing a lot from us in the coming weeks, as we do our part to help people continue to recover from these tragic events. Today, we’re providing more information for farmers and food producers who’ve been impacted by these storms, and in particular, the proper handling of crops that have been exposed to floodwaters. More information
A new qualified health claim advising that early introduction of peanuts to certain high-risk infants may reduce risk of peanut allergy
As the science governing allergies and diets continues to evolve, so do expert recommendations around how best to safely introduce babies and children to various foods. Perhaps one of the most challenging decisions for parents of my generation is when and how to introduce foods that pose a potential for a significant allergic reaction. These decisions are made more difficult as the prevalence of certain food allergies appear to be on the rise. Peanut allergy is one of the most common food allergies. It’s also one of the most dangerous. Peanut allergy is the leading cause of death related to food-induced anaphylaxis in the United States. For these reasons, it’s rightly a cause of significant concern among new parents. More information
New Generic Drug Educational Materials
The FDA is excited to announce the launch of new promotional and educational materials onwww.fda.gov/GenericDrugs to encourage communication between healthcare providers and patients around generic drugs. While nearly 90% of prescriptions filled are for generic medications, many patients have questions about whether generic medications are equal in quality, safety and effectiveness compared with brand-name versions. To encourage patients to get the facts about generic medicine, FDA has launched a new TV PSA, that will be aired in patient waiting rooms, airports, and other broadcast and cable channels. FDA is also reaching out to health care providers through print and online ads. To help answer common questions about generic medications, FDA has updated our Generic Drug Facts and Questions & Answers pages, including a new downloadable Generic Drug Facts handout. More educational materials are expected later in 2017-2018. More information
OPPORTUNITIES FOR COMMENT/GUIDANCES
Regulatory Considerations for Microneedling Devices
This draft guidance provides clarity on the regulatory pathway to market for microneedling devices, resulting in more transparency and predictability to firms and stakeholders, which may translate into more efficient device development and patient access to such devices. The scope of this guidance document does not include microneedling combination products, acupuncture needles, hypodermic needles or other needles for injection, tattoo machine needles, and needle probes that emit any type of energy (e.g., radiofrequency needles) or deliver any type of energy to a patient (e.g.,LASER, ultrasound). More information
Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access
In the Federal Register (FR) of June 22, 2017 (82 FR 28493), FDA published a notice of public meeting with a 60-day comment period to request comments on the appropriate balance between encouraging innovation in drug development and accelerating the availability to the public of lower cost alternatives to innovator drugs. After receiving extension requests to allow interested persons additional time to comment, FDA has extended the comment period.More information
Establishing and Maintaining Lists of U.S. Manufacturers/Processors With Interest in Exporting CFSAN-Regulated Products to China—21 U.S.C. 371
The United States exports a large volume and variety of foods in international trade. For certain food products, foreign governments may require assurances from the responsible authority of the country of origin of an imported food product that the manufacturer/processor of the food product is in compliance with applicable country of origin regulatory requirements. Some foreign governments establish additional requirements with which exporters are required to comply. AQSIQ Decree 145, among other requirements, mandates that foreign competent authorities provide the Certification and Accreditation Administration of China (CNCA) with a name list of overseas manufacturers of imported food applying for registration with CNCA for each commodity that CNCA has deemed to require registration. More information
Experimental Study on Warning Statements for Cigarette Graphic Health Warnings
The health risks associated with the use of cigarettes can be significant and far-reaching. In 2009, Congress enacted the Tobacco Control Act (TCA) (Pub. L. 111-31), which amends the Federal Food, Drug, and Cosmetic Act to grant FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. Section 201 of the Tobacco Control Act amends section 4 of the Federal Cigarette Labeling and Advertising Act (FCLAA) (15 U.S.C. 1333) to require FDA to issue “regulations that require color graphics depicting the negative health consequences of smoking to accompany the label statements specified in subsection (a)(1).” More information
PRODUCT APPROVALS & CLEARANCES
FDA approves first biosimilar for the treatment of cancer
The FDA approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer. “Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high, is an important way to help spur competition that can lower healthcare costs and increase access to important therapies,” said FDA Commissioner Scott Gottlieb, M.D. “We’ll continue to work hard to ensure that biosimilar medications are brought to the market quickly, through a process that makes certain that these new medicines meet the FDA’s rigorous gold standard for safety and effectiveness.” More information
FDA permits marketing of mobile medical application for substance use disorder
The FDA permitted marketing of the first mobile medical application to help treat substance use disorders (SUD). The Reset application is intended to be used with outpatient therapy to treat alcohol, cocaine, marijuana and stimulant SUDs. The application is not intended to be used to treat opioid dependence. “This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment,” said Carlos Peña, Ph.D., M.S., director of the Division of Neurological and Physical Medicine Devices in FDA’s Center for Devices and Radiological Health. “More therapy tools means a greater potential to help improve outcomes, including abstinence, for patients with substance use disorder.” More information
FDA approves new treatment for adults with relapsed follicular lymphoma
The FDA granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies. “For patients with relapsed follicular lymphoma, the cancer often comes back even after multiple treatments,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Options are limited for these patients and today’s approval provides an additional choice for treatment, filling an unmet need for them.” More information
For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA or DailyMed
PRODUCT SAFETY
MedWatch, The FDA Safety Information and Adverse Event Reporting Program
For important safety information on human drugs, medical devices, dietary supplements and more, or to report a problem with a medical product, please visit MedWatch.
Opioid Addiction Medications in Patients Taking Benzodiazepines or CNS Depressants: Drug Safety Communication - Careful Medication Management Can Reduce Risks
Based on additional review, FDA is advising that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). The combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction usually outweighs these risks. Careful medication management by health care professionals can reduce these risks. More informationUrogynecologic Surgical Mesh Implants by Boston Scientific: Notification
After extensive review of data and information from various sources available to the FDA, including data and information from Boston Scientific and results from the FDA’s own testing of the finished product, the FDA has determined that the change in supplier of the polypropylene used to manufacture Boston Scientific’s urogynecologic surgical mesh currently on the market does not raise new safety or effectiveness concerns. More information
OriGen VV28F Reinforced Dual Lumen ECMO Catheters: Recall - Potential for Separation of Extension Tube From Hub
OriGen Biomedical initiated a nationwide recall for two (2) lots of VV28F Reinforced Dual Lumen ECMO Catheters. These VV28F Reinforced Dual Lumen ECMO Catheters have been found to have the potential for a separation of the clear extension tube from the hub that it is inserted in, which potentially could result in required intervention to prevent permanent impairment/damage. OriGen Biomedical is aware of two (2) product failures and has received two (2) complaints associated with the problem. A recurrence of this event could result in serious patient injury. The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less. More information
Diabetes Infusion Sets by Medtronic: Recall - Vent Membrane May be Susceptible to Being Blocked by Fluid
Medtronic is informing patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps. The recall is related to a certain discontinued component in these infusion sets and does not include insulin pumps or glucose sensors. The company determined, through recent field reports from patients and root cause analysis, that a component, the vent membrane, in the recalled infusion sets may be susceptible to being blocked by fluid during the process of priming/fill-tubing. This situation can lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia. See the press release for affected lots and patient information. Currently manufactured infusion sets, available to patients since April 2017, include a design update of this component which the company believes reduces the risk of insulin over-delivery after an infusion set change. More information
Baby Organic Liquid Formula by Garden of Life: Recall - Directions For Use May Be Misinterpreted
Garden of Life, LLC is issuing a voluntary precautionary recall of its new supplement for infants, Baby Organic Liquid, because the product, as labeled, includes directions for use that may be misinterpreted. The company is concerned that if not administered precisely following the labeled instructions, the product may present difficulties in swallowing and potentially pose a choking hazard due to the thickness of the liquid. Baby Organic Liquid is a liquid supplement packaged in a blue carton that includes a measuring syringe. The label currently instructs parents, “Do not insert syringe directly in mouth. Dispense liquid slowly into the mouth, toward the inner cheek. May be mixed with breast milk or formula.” The company is recalling the product in order to relabel it with new instructions, advising parents to only administer the product by mixing in either breast milk or formula and not to administer directly into the infant’s mouth. This recall affects all lots of Organic Baby Liquid. Baby Organic Liquid is only sold in the USA at a limited number of natural grocers, health food stores and online. This recall arose after learning that a parent had difficulties with the safe administration of the product into a newborn’s mouth. The ingredients in Baby Organic Liquid are safe for infants. More information
Activase (alteplase) 100mg by Genentech: Recall - Lack of Sterility Assurance
Genentech is voluntarily recalling three lots of Activase (alteplase) 100mg vials, that were co-packaged with Sterile Water for Injection, to the hospital level. The vials of Sterile Water for Injection, manufactured by Hospira Inc., a Pfizer company, and packaged with Activase 100 mg, may be cracked or chipped at the neck of the vial and leaking. See press release for affected lots. The use of impacted Sterile Water for Injection could result in adverse events such as fever, chills, phlebitis, and granuloma or more severe adverse events such as sepsis or invasive systemic infections. To date, Genentech has not received reports of adverse events associated with use of impacted Sterile Water for Injection. Activase is supplied directly to hospitals and used in a hospital setting. Activase is indicated for treating patients with acute ischemic stroke (AIS), which is caused by a blood clot in the brain’s blood vessels, for treating an acute myocardial infarction (AMI), also known as a heart attack and to break apart an acute massive pulmonary embolism (PE), which is a large blood clot lodged in the blood vessels of the lung. Activase is supplied as a sterile, lyophilized powder in 100 mg vials without vacuum. More information
Intra-Aortic Balloon Pumps by Datascope/MAQUET: Class I Recall - False Blood Detection Alarm, Ingress of Fluid Into Pump
Datascope Corp./MAQUET is recalling its CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps manufactured July 1, 2003 to June 16, 2017 due to False Blood Detection Alarm and Ingress of Fluid into the Intra-Aortic Balloon Pump. If a patient requires circulatory support with an IABP and the device does not work, or if therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health consequences, including death. Datascope Corp./MAQUET's CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps are cardiac assist devices used to assist patients undergoing cardiac and non-cardiac surgery, and to treat patients with acute coronary syndrome or complications from heart failure. More information
Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Recommends Separating Dosing
FDA is recommending that patients avoid taking the potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) at the same time as other medicines taken by mouth. A study found that sodium polystyrene sulfonate binds to many commonly prescribed oral medicines, decreasing the absorption and therefore effectiveness of those oral medicines. To reduce this likelihood, we recommend separating the dosing of sodium polystyrene sulfonate from other orally administered medicines by at least 3 hours. We are updating the sodium polystyrene sulfonate drug labels to include information about this dosing separation. Sodium polystyrene sulfonate is used to treat hyperkalemia, a serious condition in which the amount of potassium in the blood is too high. It works by binding with potassium in the intestines so it can be removed from the body. Potassium is a mineral that helps the body function properly. Too much potassium in the blood can cause problems with heart rhythm, which in rare cases can be fatal. More information
UPCOMING MEETINGS
FDA advisory committee meetings are free and open to the public. No prior registration is required to attend. 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. Click on "more information" for details about each meeting.
Please visit FDA’s Advisory Committee webpage for more information. Please visit Meetings, Conferences, & Workshops for more information on other agency meetings.
SEPTEMBER
Public Meeting on Patient-Focused Drug Development for Hereditary Angioedema (Sep 25)
FDA is conducting a public meeting on Patient-Focused Drug Development for Hereditary Angioedema. FDA is interested in obtaining patient and caregiver perspectives on the on the impact of Hereditary Angioedema on daily life and patient views on treatment approaches. In addition to providing input at the public meeting, stakeholders are invited to provide their perspectives on the discussion questions through the public docket. The docket closes on November 20, 2017. More information
FDA Small Business Regulatory Education for Industry (REdI): Fall Conference (Sep 27-28)
The Regulatory Education for Industry (REdI) Conference is an FDA-led forum that brings together the regulatory educators from FDA’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH). The goal of this conference is to provide direct, relevant, and helpful information on the key aspects of drug and device regulations. Our primary audience is that of small manufacturers of drug and/or device medical products who want to learn about how FDA approaches the regulation of drugs and devices. Because the regulatory principles of drugs and devices are both similar and different, the REdI Conference features a cross-cutting plenary addressing issues which impact both drugs and devices, as well as individual break-out sessions which focus on the unique issues and regulatory requirements of drugs and devices. More information
Peripheral and Central Nervous System Drugs Advisory Committee (Sep 28)
The committee will discuss new drug application (NDA) 200896, ataluren for oral suspension, sponsored by PTC Therapeutics, Inc., for the treatment of patients with dystrophinopathy due to a nonsense mutation in the dystrophin gene. More information
OCTOBER
Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review; Public Workshop (Oct 2 - 3)
The FDA is announcing a public workshop entitled “Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review.” The workshop is intended to (1) engage stakeholders in a discussion of current and emerging scientific approaches and applications for the conduct of quantitative modeling and simulations in generic drug development, especially for complex and locally acting products, and (2) gain inputs regarding opportunities and knowledge gaps related to the use of quantitative modeling and simulation to inform regulatory decision making through the product lifecycle. The FDA will use the information gained through the workshop to support product-specific guidance development, improve pre-ANDA interactions with applicants, increase the quality and efficiency of regulatory reviews, and identify a next generation modeling and simulation toolset for complex and locally acting products. More information
CDER SBIA extended webinar: Electronic Drug Registration & Listing Using CDER Direct (Oct 5)
This in-person and on-line event is intended to educate and assist all drug firms with the registration and listing process. Each session will focus on a specific submission (Establishment Registration, Product Listing, Listing Recertification, Labeler Code Requests, 503B Product Reporting) and walk through the creation and submission of each using FDA’s free authoring tool: CDER Direct. Additionally, for those who attend in person, experts and helpdesk technicians will be on hand to answer regulatory and technical questions, and assist with submissions. More information
Public Workshop - Voluntary Medical Device Manufacturing and Product Quality Program (Oct 10)
The FDA is announcing a public workshop entitled "Voluntary Medical Device Manufacturing and Product Quality Program." The purpose of the workshop is to announce the proposed framework and preliminary outline of a voluntary pilot program that recognizes an independent assessment of manufacturing and product quality. The workshop is intended to discuss the framework of the voluntary pilot program, information on the independent assessment, details of participation, rules of engagement, monitoring and performance expectations, as well as potential modifications to FDA's oversight actions in response to demonstrated manufacturing quality performance. More information
Patient Engagement Advisory Committee Meeting Announcement (Oct 11-12)
The FDA announces a forthcoming public advisory committee meeting of the Patient Engagement Advisory Committee (PEAC). The general function of the committee is to provide advice and recommendations to the Agency on complex issues relating to medical devices, the regulation of devices, and their use by patients. The meeting will be open to the public. This meeting will be the inaugural meeting of a new advisory committee. DATES: The meeting will be held on October 11, 2017, from 1 p.m. to 5 p.m. and October 12, 2017, from 8 a.m. to 5 p.m. ADDRESSES: Hilton Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy, Gaithersburg, MD 20877. The hotel's telephone number is 301-977-8900. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/
Cellular, Tissue and Gene Therapies Advisory Committee Meeting Announcement (Oct 12)
The Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) will meet in an open session to discuss and make recommendations on the safety and effectiveness of Biologics License Application (BLA) 125610, voretigene neparvovec, submitted by Spark Therapeutics, Inc. The proposed indication (use) for this product is treatment of patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. More information
Health Canada and FDA Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (Oct 19)
The FDA is announcing a regional public meeting entitled ‘‘Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Human Use (ICH)’’ to provide information and receive comments on the current activities of ICH as well as the upcoming meetings in Geneva, Switzerland, in November 2017. The topics to be discussed are the topics for discussion at the forthcoming ICH Assembly Meeting. The purpose of the public meeting is to solicit public input prior to the next ICH Assembly meeting and the expert working groups meetings in Geneva, Switzerland, scheduled for November 11 through 16, 2016, at which the discussion of the topics underway will continue. More information
Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access (Oct 20)
The FDA is hosting a public workshop titled Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access; Public Workshop. The workshop is free to attend and open to the public. Additional details will be posted as they are available. Please check the Federal Register and this website in the coming weeks. More information
NOVEMBER
Immune Globulin Potency in the 21st Century; Public Workshop (Nov 8-9)
The FDA is conducting a public workshop entitled “Immune Globulin Potency in the 21st Century.” The purpose of the public workshop is to discuss new challenges for Industry to meet U.S. potency requirements for Immune Globulin (IG) products and to identify measures to address these challenges. The workshop has been planned in partnership with the Immune Deficiency Foundation (IDF) and the Plasma Protein Therapeutics Association (PPTA). The workshop will include presentations and panel discussions by experts from academic institutions, industry, and government agencies. More information
RESOURCES
For more important safety information on human drug and devices or to report a problem to FDA, please visitMedWatch, The FDA Safety Information and Adverse Event Reporting Program
MedWatchLearn - Practice Reporting to FDA!
This web-based learning tool teaches students, health professionals, and consumers how to complete the forms necessary to report problems to FDA. More information
Comunicaciones de la FDA sobre la seguridad de los medicamentos en español
Descargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información sobre seguridad importante en idiomas distintos al inglés. Hacemos lo mejor posible para proporcionar versiones en español precisas y oportunas de nuestras Comunicaciones de Seguridad de Medicamentos. Sin embargo, en caso que existiera discrepancias entre las versiones en ingles y en español, la información contenida en la versión en inglés es la que se considera como versión oficial. Si tiene alguna pregunta, por favor contáctese con Division of Drug Information endruginfo@fda.hhs.gov. Comunicaciones de la FDA
FDA Expert Commentary and Interview Series on Medscape
As part of the continuing collaboration between FDA and Medscape, a series of interviews and commentaries are available to communicate important safety information to clinicians. Featuring FDA experts, these original commentaries cover a wide range of topics related to FDA's multi-faceted mission of protecting and promoting the public health by ensuring the safety and quality of medical products such as drugs, foods, and medical devices. More information
Cardiovascular and Endocrine Liaison Program
The Cardiovascular and Endocrine Liaison Program serves as a liaison between the FDA and the cardiovascular and endocrine health professional and patient communities. Discover how you or your organization can collaborate with FDA. More information
Medical Product Safety Network (Medsun)
Medsun improves FDA's understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns. The Medsun newsletter provides monthly updates about timely medical device issues that may impact patient safety. More information
FDA Basics
Each month, different Centers and Offices at FDA will host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA. More information
FDA Voice
FDA voice is the official blog from FDA's senior leadership and staff. More information
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