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November 29, 2017 ANNOUNCEMENTS Statement from FDA Commissioner Scott Gottlieb, M.D., on steps to promote development of generic versions of opioids formulated to deter abuse
As we continue to confront the staggering human and economic toll created by opioid abuse and addiction, we're focused on taking actions that reduce the scope of new addiction by decreasing unnecessary exposure to opioids. At the same time, we also must take steps to help those with acute and chronic pain who need access to medicines, including opioids, get access to improved alternatives. Until we're able to find new non-opioid forms of pain management for those who need treatment for pain, it's critical that we also continue to promote the development of opioids that are harder to manipulate and abuse, and take steps to encourage their use over opioids that don't offer any form of abuse deterrence. More information
Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA's comprehensive new policy approach to facilitating the development of innovative regenerative medicine products to improve human health
One of the most promising fields of science is the area of cell-based therapies and their use in regenerative medicine. These new technologies, most of which are in early stages of development, hold transformative promise for patients. Given this area's rapid growth, dynamism and complexity, this field has also presented unique challenges to researchers, health care providers and the FDA. We need to provide a clear, efficient pathway for product developers, while making sure that we meet our obligation to help ensure the safety and efficacy of these medical products so that patients can benefit from these novel therapies. More information CDER Conversation: The FDA's Sentinel Initiative
Ensuring the safety of regulated drug products is a major part of FDA's mission. The Sentinel Initiative is a national electronic system that monitors the safety of drugs, vaccines, biologics and medical devices on the market. Started in 2008, the program has moved beyond the pilot stage into a system that works with 17 data partners disclaimer icon, such as insurance companies, HMOs, and hospitals, with access to 223 million members. Robert Ball, deputy director of CDER's Office of Surveillance and Epidemiology, discusses Sentinel's progress and future. More information
PRODUCT APPROVALS & CLEARANCES FDA approved Juluca
The FDA approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment. Juluca is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca. More information
FDA expands approval of Sutent to reduce the risk of kidney cancer returning
The FDA approved Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of kidney cancer (renal cell carcinoma) returning after a kidney has been removed (nephrectomy). Adjuvant treatment is a form of therapy that is taken after an initial surgical removal to lower the risk of the cancer coming back. More information
FDA approved new treatment to prevent bleeding in certain patients with hemophilia A
The FDA approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors. 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 The FDA Warns that Biotin May Interfere with Lab Tests The FDA is alerting the public, health care providers and laboratory personnel that biotin can interfere with certain lab tests and cause incorrect lab test results. Some supplements, particularly those labeled for hair, skin, and nail benefits, may have high doses of biotin, which may not be clear from the label. Biotin in patient samples can cause falsely high or falsely low results, depending on the test. Clinical decisions made based on incorrect laboratory test results may lead to patient harm due to inappropriate patient treatment and diagnosis. More information FDA Warns About Stem Cell Therapies
Stem cells have been called everything from cure-alls to miracle treatments. But don't believe the hype. Some unscrupulous providers offer stem cell products that are both unapproved and unproven.
The FDA has authority to regulate stem cell products in the United States. Please consider this important safety advice.
Stem cells have been called everything from cure-alls to miracle treatments. But don't believe the hype. Some unscrupulous providers offer stem cell products that are both unapproved and unproven. So beware of potentially dangerous procedures—and confirm what's really being offered before you consider any treatment. More information
Limbrel Capsules by Primus Pharmaceuticals
The FDA is investigating serious adverse events involving Limbrel, a product in capsule form currently being marketed as a medical food to manage the metabolic processes associated with osteoarthritis. While a range of adverse events have been reported, two serious and potentially life-threatening medical conditions are among them: drug-induced liver injury and hypersensitivity pneumonitis. More information
Greenstone Issues Voluntary Nationwide Recall of Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, USP Due to Possible Sub Potent and Super Potent Tablets
Greenstone LLC, a wholly owned subsidiary of Pfizer Inc., is voluntarily recalling multiple lots of diphenoxylate hydrochloride and atropine sulfate tablets, USP to the consumer level. Greenstone initiated this recall because product from these lots has the potential to be super potent or sub potent. Diphenoxylate hydrochloride and atropine sulfate tablets are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older. Diphenoxylate hydrochloride and atropine sulfate tablets are contraindicated in pediatric patients less than 6 years of age due to the risks of respiratory and central nervous system (CNS) depression. More information
Sun Pharmaceutical Industries Inc. Issues Voluntary Nationwide Recall of Riomet® (Metformin Hydrochloride Oral Solution) Manufactured by a Contract Manufacturer due to Microbial Contamination
"Sun Pharma" including its subsidiaries and/or associate companies) is voluntarily recalling two lots of Riomet® (Metformin Hydrochloride Oral Solution), 500 mg/5mL, to the retail level (Class II Recall). This product is manufactured for SPII by a contract manufacturer. The Riomet® (Metformin Hydrochloride Oral Solution) has been found to be contaminated (Scopulariopsis brevicaulis). More information 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.
DRUG SHORTAGES Drug Shortages Discontinued 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 and Vaccines, Blood and Biologic Shortages
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. DECEMBER
FDA's Division of Drug Information (DDI) in the Center for Drug Evaluation and Research (CDER) is presenting a series of continuing education webinars targeting the needs of all health care professionals.
DDI Webinar Series: Overview of the Regulatory Framework and the Development and Approval of Biosimilar Products in the U.S.
December 5, 2017
Time: 1:00 pm to 2:00 pm (EST)
For more information and to register please see www.fda.gov/DDIWebinars Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee (Dec. 7)
The committee will discuss appropriate patient selection criteria and clinical trial design features, including acceptable endpoints, for demonstrating clinical benefit for drugs intended to treat interstitial cystitis and bladder pain syndrome. The committee will also discuss whether bladder pain syndrome and interstitial cystitis reflect overlapping or different populations, and whether it is appropriate to assess efficacy in the same way for both conditions. More information
Packaging, Storage, and Disposal Options to Enhance Opioid Safety-Exploring the Path Forward (Dec. 11-12)
The purpose of the public workshop is to host a scientific discussion with expert panel members and interested stakeholders regarding the role of packaging, storage, and disposal options within the larger landscape of activities aimed at addressing abuse, misuse, or inappropriate access of prescription opioid drug products (opioids); guiding principles and considerations for the design of packaging, storage, and disposal options for opioids; integrating packaging, storage, and disposal options into existing health care and pharmacy systems. More information
Medical Gas Regulation Public Workshop (Dec. 15)
The FDA is holding these workshops to provide an opportunity for medical gas manufacturers and any other interested members of the public to provide input on potential areas of Federal drug regulation that should be revised with respect to medical gases. More information
Public Workshop on Patient-Focused Drug Development: Guidance 1 – Collecting Comprehensive and Representative Input (Dec. 18)
The FDA is conducting a public workshop to convene a discussion on methodological approaches that a person seeking to collect patient experience data for submission to FDA to inform regulatory decision-making may use. The workshop will focus on topics related to approaches to collecting comprehensive and representative patient and caregiver input on burden of disease and current therapy. This workshop will inform development of patient-focused drug development guidance as required by the 21st Century Cures Act and to meet a performance goal included in the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA VI). More information
RESOURCES
For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch, The FDA Safety Information and Adverse Event Reporting Program
FDA Drug Info Rounds
Drug Info Rounds is a series of training videos created and produced by pharmacists in FDA's Center for Drug Evaluation and Research, Office of Communications, Division of Drug Information (DDI). DDI pharmacists respond to over 70,000 inquiries per year about FDA initiatives and regulated drugs from healthcare professionals, industry, and consumers. The Drug Info Rounds video series provides important and useful drug information to health care providers helping them be better clinicians and, ultimately, improving patient safety.
In this video, the FDA Drug Info Rounds pharmacists discuss how FDA works with both domestic and foreign drug manufacturers to help ensure that products distributed within the United States meet U.S. requirements and standards for product safety and quality.
To watch the video, please visit: FDA's Role in Foreign Drug Manufacturing.
All videos are available at: FDA Drug Info Rounds.
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 en druginfo@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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