March 21, 2018
ANNOUNCEMENTS
FDA updates public information about known risk of lymphoma from breast implants
FDA updated information about its understanding of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The agency is providing an updated number of medical device reports (MDRs) (also known as adverse event reports) and medical literature estimates regarding risk reviewed by the agency since the last public update in March 2017. FDA is aware of 414 total cases of BIA-ALCL. Additionally, studies reported in medical literature estimate that the lifetime risk of developing BIA-ALCL for patients with textured breast implants ranges from 1 in 3,817 to 1 in 30,000.
Efforts to reduce tobacco use, especially among youth, by exploring options to address the role of flavors - including menthol - in tobacco products - Statement from FDA Commissioner Scott Gottlieb, M.D.
FDA issuing an advance notice of proposed rulemaking (ANPRM) and calling upon all stakeholders to share data, research and information that can inform our process for examining the role that flavors – including menthol – play in initiation, use and cessation of tobacco products. We want to consider the most impactful regulatory options the FDA could pursue to address this issue.
Pivotal public health step to dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels - Statement from FDA Commissioner Scott Gottlieb, M.D.
New regulatory step advances a comprehensive policy framework that we believe could help avoid millions of tobacco-related deaths across the country.
FDA warns duodenoscope manufacturers about failure to comply with required postmarket surveillance studies to assess contamination risk.
FDA issued warning letters to all three duodenoscope manufacturers for failing to comply with requirements of federal law under which they were ordered to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the devices.
U.S. House Committee on Energy and Commerce Subcommittee on Oversight and Investigations hearing “Examining U.S. Public Health Preparedness for and Response Efforts to Seasonal Influenza.” Remarks from FDA Commissioner Scott Gottlieb, M.D.
DRUG SHORTAGES
Lamivudine and Zidovudine Tablets (Discontinuation)
Lamivudine Tablets (Discontinuation)
Zolpidem Tartrate (Edluar) Sublingual Tablets (Currently in Shortage)
Lamivudine Tablets (Discontinuation)
Zolpidem Tartrate (Edluar) Sublingual Tablets (Currently in Shortage)
PRODUCT APPROVALS & CLEARANCES
FDA expands approval of Adcetris for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy
FDA approved Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy. Adcetris combines an antibody and drug, allowing the antibody to direct the drug to a target on lymphoma cells known as CD30. Adcetris has also been previously approved by the FDA to treat cHL after relapse, cHL after stem cell transplant when a patient is at a high risk of relapse or progression, systemic anaplastic large cell lymphoma (ALCL) after failure of other treatment, and primary cutaneous ALCL after failure of other treatment.
For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA or DailyMed
PRODUCT SAFETY
Kratom-containing Powder Products by PDX Aromatics: Recall - Potential for Contamination with Salmonella
UPDATED 03/20/2018. Recall expanded to include additional lots. Salmonella contamination can cause serious and sometimes fatal infections in young children, frail or elderly people.
Alka-Seltzer Plus Products: Recall - Ingredients on Front Sticker May Not Match Product in Carton
Consumers may ingest a product to which they may have an allergy or anaphylactic reaction, an ingredient which may be contraindicated for their condition or they intend to otherwise avoid, with potential for serious health consequences.
Compounded Glutamine, Arginine, and Carnitine Product for Injection by United Pharmacy: Compounding Risk Alert - FDA Investigates Two Adverse Events
UPDATED 03/16/2017. Glutamine in United Pharmacy’s compounded GAC 10/100/200 mg/mL product for injection is degrading before the beyond-use date (BUD) of 6 months specified on the product label.
Neurovascular Embolization Coils: Healthcare Provider Letter - Potential for Increased Image Artifact When Using Magnetic Resonance Angiography For Follow-Up
Reduced quality of MRA image from increased artifact can result in inaccurate clinical diagnoses (e.g., occlusion status) and subsequent inappropriate medical decisions.
For important safety information on human drugs, medical devices, dietary supplements and more, or to report an adverse event or problem with a medical product, please visit MedWatch, The FDA Safety Information and Adverse Event Reporting Program.
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.
MARCH
Pediatric Advisory Committee Meeting (Mar 23)
Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003. The Pediatric Advisory Committee will meet to discuss the following products: Center for Drug Evaluation and Research: BANZEL, INTUNIV, LEXAPRO
Center for Devices and Radiological Health: FLOURISH (HDE), ACTIVA (HDE), LIPOSORBER (HDE), IMPELLA RP SYSTEM (HDE)
APRIL
US FDA and Health Canada: Joint Regional Consultation on the ICH (Apr 6)
FDA and Health Canada will cohost a regional public meeting entitled ‘‘United States Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)’’ to provide information and receive comments on the current activities of ICH as well as the upcoming meetings in Kobe, Japan scheduled for June 4 through 7, 2018. The topics for discussion include the current ICH guideline topics under development that will be discussed at the forthcoming ICH Assembly Meeting in Kobe – see agenda for list of discussion topics. The purpose of this public meeting is to solicit public input prior to the next ICH Assembly meeting and expert working group meetings in Kobe.
FDA Drug Topics: An Introduction to Drug Safety Surveillance and the FDA Adverse Event Reporting System (Apr 10)
This webinar will introduce the many phases of drug safety surveillance from the earliest stages of drug development through post approval, and will focus on how FDA conducts pharmacovigilance, develops safety signals, and communicates our findings.
CDER Small Business and Industry Assistance Regulatory Education for Industry (REdI): Generic Drugs Forum (Apr 11 -12)
FDA led Regulatory Education for Industry (REdI): Generic Drugs Forum 2018. Join over 1000 participants from across the globe as we gather together in this opportunity to interact with FDA subject matter experts involved in the Generic Drug Review Program. Obtain up-to-date information on program progress and current initiatives.
2018 AAPS Workshop on Drug Transporters in ADME: From the Bench to the Bedside (Apr 16-18)
The 2018 AAPS Transporter Workshop will be the ninth workshop developed to present the next generation of transporters and transport mechanisms that may contribute to absorption, distribution, metabolism and excretion (ADME ) properties of drugs in disease states that should be considered in drug discovery and development. This state-of-the-art workshop will present contributions of heteromeric transporters (ABCG5/G8, ABCD2, OSTa/ß) to biliary excretion of cholesterol and disease states, as well as examining intracellular mechanisms of lysosomal sequestration, large molecule transport (antibody, siRNA, antisense RNA) and the current state-of-the-art in transporter imaging, 3D culture models, and in silico approaches to predicting transporter substrate and inhibitor activity.
Peripheral and Central Nervous System Drugs Advisory Committee Meeting (Apr 19)
The committee will discuss new drug application (NDA) 210365, cannabidiol oral solution, sponsored by GW Pharmaceuticals, for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.
FDA/OCE Public Meeting on Relevant Molecular Targets in Pediatric Cancers: Applicability to Therapeutic Investigation FDARA 2017 (Apr 20)
The FDA Oncology Center of Excellence will hold a public meeting to review and discuss a provisional list of molecular targets to which drugs are being developed for adult cancer indications but which may also be relevant to the growth and/or progression of a cancer which occurs predominantly in children thereby providing a possible rationale for early pediatric evaluation. This meeting is intended for multi-stakeholder participation and input to the Food and Drug Administration as it responds to its FDARA mandate to develop, post on the FDA website, and update regularly such a list to guide sponsors as to which molecular mechanism of action-specific targeted cancer drugs might be considered for early evaluation in children.
Arthritis Advisory Committee Meeting (Apr 23)
The committee will discuss the new drug application (NDA) 207924, for baricitinib tablets, submitted by Eli Lilly and Company, for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The discussion will include the following: efficacy, safety, including the risk of thromboembolic adverse events, dose selection, and overall risk benefit considerations.
12th Annual FDA/DIA Biostatistics Industry and Regulator Forum 2018 (Apr 23-25)
This meeting is intended to be an open forum for the timely discussion of topics of mutual interest to statisticians and clinical trialists who develop new drugs and biologics. A primary focus for this meeting will be to establish an on-going dialogue between industry and regulatory agencies regarding the role of statisticians in implementing the goals and commitments outlined in the sixth authorization of the Prescription Drug User Fee Act.
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.
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.
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.
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.
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.
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.
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.
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