February 21, 2018
FDA Drug Topics: FDA’s MedWatch Adverse Reporting Program – Opportunities to Collaborate
FDA’s Division of Drug Information 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
and students. Will be held on: March 13, 2018; Time: 1:00 pm to 2:00 pm (EDT)
FDA issued a final rule titled “Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices”
The rule updates the FDA’s standards for accepting clinical data from medical device studies conducted outside of the U.S. to support a device research or marketing application or submission, including 510(k), De Novo, humanitarian device exemption, as well as premarket approval.
FDA Commissioner Scott Gottlieb, M.D. statement on the efficacy of the 2017-2018 influenza vaccine
Seasonal flu has been widespread this year, impacting millions of people across the country. It has been an especially challenging season, with high rates of hospitalization for both influenza and its complications, which include pneumonia and the exacerbation of chronic conditions such as asthma and congestive heart failure.
Statement on advancing the development of novel treatments for neurological conditions; part of broader effort on modernizing FDA’s new drug review programs
New medical breakthroughs are altering how diseases are treated in ways that seemed unimaginable just a decade ago. Perhaps one of the most significant developments is the advent of new gene therapies and drugs that boost the immune system’s ability to target tumor cells.
Statement on Administration’s request for new FDA funding to promote innovation and broaden patient access through competition
New scientific opportunities, as well as advances in manufacturing and commerce, give the FDA new ways to advance our mission to protect and promote public health. Leveraging these opportunities requires us to make investments in regulatory science that can reduce uncertainty for innovators, spur investment in new industries and provide principles for the safe and effective development of new technologies.
Statement on groundbreaking approval and interagency approach to bring stable supply of critical medical imaging isotope to the U.S.
The RadioGenix System is a novel manufacturing system for producing radioisotope called Technetium-99m (Tc-99m). Tc-99m plays a vital role in nuclear imaging studies for a wide range of uses, including cancer and cardiology.
FDA and NRC pave way for the first domestic supply of the most commonly used medical isotope in diagnostic imaging
The FDA the Nuclear Regulatory Commission (NRC) took steps to ensure a stable and secure supply of a critical radioactive imaging product used to detect potentially life-threatening diseases.
- Bupivacaine Hydrochloride and Epinephrine Injection, USP (New - Currently in Shortage)
- Bupivacaine Hydrochloride Injection, USP (New - Currently in Shortage)
- Ketamine Injection (New - Currently in Shortage)
- Lidocaine Hydrochloride Injection (New - Currently in Shortage)
PRODUCT APPROVALS & CLEARANCES
FDA expands approval of Imfinzi to reduce the risk of non-small cell lung cancer progressing
The FDA approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation).
FDA expands treatment window for use of clot retrieval devices in certain stroke patients
The FDA cleared the use of the Trevo clot retrieval device to treat certain stroke patients up to 24 hours after symptom onset, expanding the device’s indication to a broader group of patients
FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint
The FDA approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant).
FDA authorizes marketing of first blood test to aid in the evaluation of concussion in adults
The FDA permitted marketing of the first blood test to evaluate mild traumatic brain injury (mTBI), commonly referred to as concussion, in adults.
FDA permits marketing of clinical decision support software for alerting providers of a potential stroke in patients
The FDA permitted marketing of the Viz.AI Contact application, a type of clinical decision support software designed to analyze computed tomography (CT) results that may notify providers of a potential stroke in their patients.
For more information on drug approvals or to view prescribing information and patient information, please visitDrugs@FDA or DailyMed
Acyclovir 400mg Tablets by Apace Packaging: Recall - Product Mix-up Missing a dose of Acyclovir Tablets could cause a reactivation of a virus being treated
Apace Packaging LLC is voluntarily recalling one lot of Acyclovir Tablet, USP, 400mg, 50ct Unit Dose, NDC# 50268-061-15, Lot Number 19900, to the retail level. These products have been recalled due to a product mix-up.
HeartStart MRx Defibrillator by Philips Electronics: Class I Recall - Defects in Gas Discharge Tubes May Cause Device Failure
The GDT has micro cracks which allows internal gasses to escape and causes the tubes to not function as expected
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.
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.
Neurological Devices Panel of the Medical Devices Advisory Committee Meeting (Mar 1)
The committee will discuss, make recommendations, and advise FDA regarding the evaluation of clinical study data to support the safety and effectiveness of intracranial aneurysm treatment devices and factors that can affect clinical outcomes such as aneurysm morphology, size, and location in the neurovasculature. FDA is also convening this committee to seek expert opinion on the scientific and clinical considerations relating to the clinical trial design that may be relevant to the determination of safety and effectiveness for these devices.
IASLC-FDA Lung Cancer Neoadjuvant Meeting (Mar 1-2)
This initial meeting between the FDA, the IASLC, industry and investigators is designed to facilitate discussions regarding the standardization of endpoints in neoadjuvant lung cancer trials and to discuss how said endpoints can be validated by comparing novel endpoints to established time to event endpoints.
Risk Communication Advisory Committee Meeting Announcement (Mar 5)
The committee will discuss the impact of pregnancy and lactation labeling information in prescription drug and biological products as modified under the Pregnancy and Lactation Labeling Rule.
Gastrointestinal Drugs Advisory Committee Meeting (Mar 8)
The committee will discuss supplemental new drug application (sNDA) 203214, supplement 18, XELJANZ (tofacitinib) 5 mg and 10 mg tablets, submitted by Pfizer Inc., proposed for the treatment of adult patients with moderately to severely active ulcerative colitis who have demonstrated an inadequate response, loss of response or intolerance to corticosteroids, azathioprine, 6-mercaptopurine or tumor necrosis factor (TNF) inhibitor therapy.
Oncology Center of Excellence Listening Session; Public Meeting (Mar 15)
The purpose of the public meeting and the docket for comments is for stakeholders to provide recommendations to the Agency regarding FDA's OCE. Specifically, the Agency solicits comments regarding what stakeholders desire of the OCE in terms of structure, function, regulatory purview, and activity.
Pediatric Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement (Mar 22)
Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) will meet to discuss the major objectives of a phase 3 drug development program indicated for the treatment of children with achondroplasia (ACH) submitted by BioMarin Pharmaceutical Inc.
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)
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 firstname.lastname@example.org.
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 voice is the official blog from FDA's senior leadership and staff.
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