ANNOUNCEMENTS
FDA orders mandatory recall for kratom products due to risk of salmonella
U.S. Food and Drug Administration announced it has issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several were found to contain salmonella. The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall. This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products.
FDA’s efforts to enhance the patient perspective and experience in drug development and review - Statement from FDA Commissioner Scott Gottlieb, M.D.
Benefit-risk assessment is at the heart of what we do to ensure that Americans have access to medical products that are safe, effective and meet their needs. But we’re also deeply aware that serious chronic illnesses aren’t monolithic. Patient perception of the benefits and risks of different treatment options can vary based on the stage of the disease, the age of onset, alternative therapies available to treat the disease (if any) and whether a novel therapy improves a patient’s ability to function normally, slows the rate of disease progression or impacts other aspects of a patient’s quality of life.
Key step in advancing FDA’s oversight of drug compounding and implementing new laws governing outsourcing facilities - Statement from FDA Commissioner Scott Gottlieb, M.D.
On March 23, 2018 FDA took a key step forward in implementing the Drug Quality and Security Act (DQSA) and section 503B of the Federal Food, Drug, and Cosmetic Act. Among other things, these provisions limit the bulk drug substances that outsourcing facilities can use in compounding. It directs the FDA to develop a list of bulk drug substances for which there is a clinical need – the 503B bulks list. FDA issued a critical policy document that addresses how that list will be formulated, and what bulk drug substances the outsourcing facilities can use to compound drugs.
Findings from ongoing investigation into lead testing issues - FDA Statement
FDA has remained in close contact with lead test manufacturer Magellan Diagnostics as well as Becton Dickinson (BD) & Company, the manufacturer of certain blood sample collection tubes often used alongside many lead tests, as part of our effort to determine the cause of inaccurate results.
DRUG SHORTAGES
Liothyronine Sodium Tablets (Discontinuation)
Ropivacaine Hydrochloride injection (Currently in Shortage)
Ketorolac Tromethamine Injection (Currently in Shortage)
Phenytoin Sodium Injection, USP (Currently in Shortage)
Ropivacaine Hydrochloride injection (Currently in Shortage)
Ketorolac Tromethamine Injection (Currently in Shortage)
Phenytoin Sodium Injection, USP (Currently in Shortage)
PRODUCT APPROVALS & CLEARANCES
FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse
FDA granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). MRD refers to the presence of cancer cells below a level that can be seen under the microscope. In patients who have achieved remission after initial treatment for this type of ALL, the presence of MRD means they have an increased risk of relapse.
FDA authorizes first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices
FDA permitted marketing of the Dexcom G6 integrated continuous glucose monitoring (iCGM) system for determining blood glucose (sugar) levels in children aged two and older and adults with diabetes. This is the first type of continuous glucose monitoring system permitted by the agency to be used as part of an integrated system with other compatible medical devices and electronic interfaces, which may include automated insulin dosing systems, insulin pumps, blood glucose meters or other electronic devices used for diabetes management.
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 Products by Triangle Pharmanaturals: Mandatory Recall - Risk of Salmonella
Salmonella bacteria can cause the foodborne illness salmonellosis. Most people infected with salmonella develop diarrhea, fever and abdominal cramps 12 to 72 hours after infection.
Dietary Supplements by Nutrizone: Recall - Potential for Salmonella Contamination
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Pasta De Lassar Andromaco Skin Protectant 25 Percent Zinc Oxide by MarcasUSA: Recall - Potential Contamination
Use of the contaminated product could result in an increased risk of infection.
Eclipse Kratom by Tamarack: Recall - Possible Salmonella Contamination
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
BD Vacutainer Blood Collection Tubes by Becton, Dickinson and Company (BD): Class I Recall - Chemical Interference with Certain Tests
Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning.
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.
LeadCare Testing Systems (with Blood Obtained from a Vein) by Magellan Diagnostics: FDA Safety Communication - Risk of Inaccurate Results
UPDATED 03/22/2018. FDA has concluded that one of the contributing factors to the inaccurate LeadCare test results is the chemical composition of the rubber stoppers of certain blood collection tubes.
NeuroBlate Probe by Monteris Medical: Letter to Health Care Providers, Class I Recall - Unintended Heating
Instances of unintended heating and damage to the probe, which may have resulted in unintended damage to surrounding brain tissue.
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.
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.
MAY
Antimicrobial Drugs Advisory Committee Meeting (May 2)
The committee will discuss new drug application (NDA) 210303 for plazomicin, sponsored by Achaogen Inc., for the proposed indications for the treatment of complicated urinary tract infections and blood stream infections in adults.
Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Pediatric Advisory Committee Meeting (May 3)
The committees will discuss new drug application (NDA) 209904, for stannsoporfin injection, for intramuscular use, submitted by InfaCare Pharmaceutical Corporation, proposed for the treatment of neonates greater than or equal to 35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe hyperbilirubinemia.
Tissue Agnostic Therapies: Regulatory Considerations for Orphan Drug Designation; Public Workshop (May 9)
The FDA is holding a public workshop to discuss factors FDA should consider when evaluating drugs for orphan designation that treat a tissue agnostic disease or condition in oncology, and additional factors related to orphan exclusivity FDA should consider when approving a product with a tissue agnostic indication.
Endocrinologic and Metabolic Drugs Advisory Committee Meeting (May 10)
The committee will discuss the safety and efficacy of new drug application (NDA) 210645, for volanesoren solution for subcutaneous injection, submitted by Akcea Therapeutics, Inc. The proposed indication is as an adjunct to diet for the treatment of patients with familial chylomicronemia syndrome.
Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee (May 22)
The committees will be asked to discuss new drug application (NDA) 209588, for buprenorphine sublingual spray, submitted by INSYS Development Company, Inc., for the treatment of moderate-to-severe acute pain where the use of an opioid analgesic is appropriate. The committees will also be asked to discuss whether this product should be approved.
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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