October 04, 2017
ANNOUNCEMENTS
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 very sick if they eat gluten, a mixture of proteins that occur naturally in grains and are found in many foods, including breads, cakes, cereals and pastas. 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 that defines the characteristics a food has to have to bear such a claim. More information
FDA in Brief: FDA warns of risk of legal blindness with eye injections of compounded drugs containing vancomycin
FDA issued a Compounding Risk Alert concerning an adverse event associated with compounded triamcinolone, moxifloxacin and vancomycin (TMV) for intraocular injection. The FDA received an adverse event report on Aug. 14, 2017, from a physician concerning a patient who was diagnosed postoperatively with bilateral hemorrhagic occlusive retinal vasculitis (HORV), which is a rare, potentially blinding postoperative complication that has been observed in dozens of patients who have received intraocular injections of vancomycin (anti-infective) formulations toward the end of otherwise uncomplicated cataract surgeries. On Sept. 28, 2017, the agency approved a supplemental new drug application that adds a subsection about HORV to the WARNINGS section of the prescribing information in the labeling of the FDA approved Vancomycin Injection, USP. More information
New efforts to encourage compounding of better quality drugs under DQSA and help health care professionals access compounded medications needed for patient care from outsourcing facilities - Statement from FDA Commissioner Scott Gottlieb, M.D.
As a physician, I understand how important it is for health care providers to have access to compounded drugs when the needs of their patients cannot be met by FDA-approved drugs. Our commitment to implementing and enforcing the Drug Quality and Security Act (DQSA) provides a pivotal foundation for achieving these goals. FDA oversight of compounding continues to remain essential, because compounded drugs, while important to patients who need them, pose ongoing and serious risks if they are not manufactured properly. Every year, the FDA learns of cases of patient illnesses and deaths due to improperly compounded drugs and caused by issues like contamination in drugs that need to be sterile because they are entering the bloodstream, the eye, or the spine or because the drugs are not made at the right strength and are super-potent.
More information
FDA selects participants for new digital health software precertification pilot program
FDA announced the names of the companies selected to participate in a first-of-its kind pilot program that will help revolutionize digital health regulation in the U.S. The FDA’s Pre-cert pilot program is intended to inform a tailored approach toward digital health technology by looking at the software developer or digital health technology developer, rather than primarily at the product. The goal of this new approach is for the FDA to, after reviewing systems for software design, validation and maintenance, determine whether the company meets quality standards and if so, to precertify the company. More information
FDA actions to bring relief to citizens of Puerto Rico; to help the island recover its considerable and economically vital medical product manufacturing base; and to prevent critical shortages of life-saving drugs made in Puerto Rico - Statement from FDA Commissioner Scott Gottlieb, M.D.
As an agency dedicated to promoting public health, and as fellow Americans, the staff at the U.S. Food and Drug Administration is doing all it can to support the immediate needs of Puerto Ricans following the destruction of Hurricane Maria. First and foremost, these efforts are focused around our mission driven responsibilities to ensure the safety of the medical products, blood and the food supply needed by residents of the island. Our efforts also encompass challenges that are unique to Puerto Rico. The island is home to a substantial base of manufacturing for critical medical products that supply the entire world. This industrial base is an important source of jobs and economic vitality for the island. It is a key to Puerto Rico’s economic recovery. The manufacturing facilities are also a pivotal source of critical medical products for the entire United States. Helping to bring these resources back in operation is an important goal of ours and of Puerto Rico’s. More information
FDA conducts major global operation to protect consumers from potentially dangerous prescription drugs sold online
FDA, in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids, antibiotics and injectable epinephrine products to American consumers. These actions were part of a major global operation that the FDA participated in to target illegal drugs being marketed online, and shipped and distributed through the postal system, directly to American consumers. Among other actions, the FDA also issued warning letters to the operators of a majority of the illegal websites that were targeted in the operation and worked with internet registrars to confiscate certain websites. More information
FDA's continued efforts to promote the safe adoption of medication-assisted treatment for opioid addiction - Statement from FDA Commissioner Scott Gottlieb, M.D.
Medication-assisted treatment (MAT) – the use of medication combined with counseling and behavioral therapies – is one of the major pillars of the federal response to the opioid epidemic in this country. This type of treatment is an important tool that has the potential to help millions of Americans with an opioid use disorder regain control over their lives. In fact, patients receiving MAT cut their risk of death from all causes in half, according to the Substance Abuse and Mental Health Services Administration. Addressing the epidemic of opioid addiction is my highest public health priority. One element of that effort is promoting more widespread, safe adoption of MAT as a way to help more people overcome addiction. 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
PRODUCT APPROVALS & CLEARANCES
FDA approves new treatment for certain advanced or metastatic breast cancers
FDA approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient’s hormones (endocrine therapy). Verzenio is approved to be given in combination with an endocrine therapy, called fulvestrant, after the cancer had grown on endocrine therapy. It is also approved to be given on its own, if patients were previously treated with endocrine therapy and chemotherapy after the cancer had spread (metastasized). More information
FDA approves first continuous glucose monitoring system for adults not requiring blood sample calibration
FDA approved the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that can be used by adult patients to make diabetes treatment decisions without calibration using a blood sample from the fingertip (often referred to as a “fingerstick”). The system reduces the need for fingerstick testing by using a small sensor wire inserted below the skin’s surface that continuously measures and monitors glucose levels. Users can determine glucose levels by waving a dedicated, mobile reader above the sensor wire to determine if glucose levels are too high (hyperglycemia) or too low (hypoglycemia), and how glucose levels are changing. It is intended for use in people 18 years of age and older with diabetes; after a 12-hour start-up period, it can be worn for up to 10 days. More information
FDA clears first duodenoscope with disposable distal cap
FDA cleared the first duodenoscope with a disposable distal cap, a new feature that will improve access for cleaning and reprocessing. The Pentax ED34-i10T model duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems. 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.
Intraocular Injections of a Compounded Triamcinolone, Moxifloxacin, and Vancomycin (TMV) Formulation: FDA Statement - Case of Hemorrhagic Occlusive Retinal Vasculitis
Prophylactic use of intraocular vancomycin, alone or in a compounded drug, during cataract surgery is generally not recommended because of the risk of HORV. More information
Infant Sleep Positioners: FDA Warning - Risk of Suffocation
FDA reminding parents and caregivers not to put babies in sleep positioners. These products, sometimes also called “nests” or “anti-roll” products, can cause suffocation that can lead to death. More information
Endovascular Graft Systems: Letter to Health Care Providers - Type III Endoleaks Associated with Use
Type III endoleak may require treatment with additional interventions such as re-lining, insertion of additional endograft components, or open surgical repair. Interventions to address endoleaks carry added risks for impacted patients. More information
Bridge Occlusion Balloon Catheter Model 590-001 by Spectranetics: Class I Recall - Risk of Blocked Guidewire Lumen Preventing Balloon Utilization
If device with blocked guidewire lumen were used, device would not be positioned correctly and hemorrhage would not be controlled, delaying life-saving treatment, which may result in serious adverse health consequences, including death. More information
TAH-t Companion 2 Driver System (C2) and Freedom Driver System by SynCardia Systems: Letter to Health Care Providers - Mortality and Neurological Adverse Event Results
UPDATED. Most recent interim results from the ongoing SynCardia TAH-t post-approval study looking at mortality and neurological adverse events. More information
Vegetable Vigra by Natures Supplement: Recall - Undeclared Drug Ingredient
Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that, taken with this product, could lower blood pressure to dangerous levels that could be life-threatening. More information
Ocaliva (obeticholic acid): Drug Safety Communication - Increased Risk of Serious Liver Injury
Reports of Ocaliva being incorrectly dosed in some patients with moderate to severe decreases in liver function. Some patients received a higher frequency of dosing than is recommended in the drug label. More information
Rhino 7, Papa Zen, Fifty Shades, and Grande X Dietary Supplements by Gadget Island: Recall - Undeclared Drug Ingredients
Use of products with undeclared active ingredients sildenafil, tadalafil and desmethyl carbodenafil may interact with nitrates and may cause a significant drop in blood pressure that may be life threatening. 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.
OCTOBER
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
Vaccines and Related Biological Products Advisory Committee Meeting Announcement (Nov 7)
On November 7, 2017, the Vaccines and Related Biological Products Committee (VRBPAC) will meet in an open session to discuss and make recommendations on the clinical development plan for Pfizer’s investigational Staphylococcus aureus vaccine intended for pre-surgical prophylaxis in elective orthopedic surgical populations. More information
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
Partners in Progress: Cancer Patient Advocates and FDA (Nov 13)
The FDA Oncology Center of Excellence announces the first annual educational workshop for new cancer patient advocates entitled, "Partners in Progress: Cancer Patient Advocates and FDA." The meeting will be held on November 13, 2017, from 9 am-4 pm at the FDA White Oak Campus, Building 31 Great Room, 10903 New Hampshire Avenue, Silver Spring, MD. The objectives of this meeting are to provide basic training on the role of the FDA and cancer patient advocates in oncology product development. This broad introduction to FDA regulatory aspects of oncology product development will be most relevant to attendees with limited knowledge and experience in cancer product development and patient advocacy. Support for this meeting is provided by the following organizations: The American Association for Cancer Research (AACR), the American Society of Clinical Oncology (ASCO), and the American Society of Hematology (ASH). Financial assistance is not available for travel-related expenses for this meeting. 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
Opportunities for Comment
The FederalRegister.gov website was developed to make it easier for citizens and communities to understand the regulatory process and to participate in Government decision-making. The Office of the Federal Register of the National Archives and Records Administration and the U.S. Government Publishing Office jointly administer the FederalRegister.gov website. Search for opportunities to comment on FDA Public Notices.
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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