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FDA Deem Regulation

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https://www.readbyqxmd.com/read/27709305/analysis-of-the-safety-evaluation-for-premarketing-clinical-trials-of-hemodialyzer-and-of-postmarketing-safety-reports-of-hemodialyzer-in-japan-and-the-us-insights-into-the-construction-of-a-sophisticated-premarketing-evaluation
#1
Masami Saito, Kiyotaka Iwasaki
Our aim was to conduct a scoping review of the regulations for hemodialyzers in the safety evaluation in Japan and the United States, and to evaluate the criteria for premarketing clinical trials and postmarketing safety reports to inform the development of a sophisticated premarketing evaluation in Japan. Regulations for approval of hemodialyzers were identified from the databases of the Ministry of Health, Labor and Welfare in Japan and the Federal Drug Agency (FDA) in the United States (US). The criteria for premarket clinical trials and postmarketing safety reports were evaluated for both countries...
October 5, 2016: Journal of Artificial Organs: the Official Journal of the Japanese Society for Artificial Organs
https://www.readbyqxmd.com/read/27192730/deeming-tobacco-products-to-be-subject-to-the-federal-food-drug-and-cosmetic-act-as-amended-by-the-family-smoking-prevention-and-tobacco-control-act-restrictions-on-the-sale-and-distribution-of-tobacco-products-and-required-warning-statements-for-tobacco-products
#2
(no author information available yet)
The Food and Drug Administration (FDA) is issuing this final rule to deem products meeting the statutory definition of "tobacco product,'' except accessories of the newly deemed tobacco products, to be subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The Tobacco Control Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law...
May 10, 2016: Federal Register
https://www.readbyqxmd.com/read/26995792/is-the-e-liquid-industry-regulating-itself-a-look-at-e-liquid-internet-vendors-in-the-united-states
#3
Dmitriy Nikitin, David S Timberlake, Rebecca S Williams
INTRODUCTION: The objective of this study was to assess whether the nascent, but rapidly growing e-liquid industry prohibits Internet sales to minors and employs safety measures to prevent accidental poisonings. METHODS: A stratified simple random sample (n = 120) was selected from the target population (N = 1107) of US online vendors of e-liquid in July 2015. The vendors were stratified and subsequently oversampled by trade association membership and vendor popularity...
October 2016: Nicotine & Tobacco Research: Official Journal of the Society for Research on Nicotine and Tobacco
https://www.readbyqxmd.com/read/26408554/will-chronic-e-cigarette-use-cause-lung-disease
#4
REVIEW
Temperance R Rowell, Robert Tarran
Chronic tobacco smoking is a major cause of preventable morbidity and mortality worldwide. In the lung, tobacco smoking increases the risk of lung cancer, and also causes chronic obstructive pulmonary disease (COPD), which encompasses both emphysema and chronic bronchitis. E-cigarettes (E-Cigs), or electronic nicotine delivery systems, were developed over a decade ago and are designed to deliver nicotine without combusting tobacco. Although tobacco smoking has declined since the 1950s, E-Cig usage has increased, attracting both former tobacco smokers and never smokers...
December 15, 2015: American Journal of Physiology. Lung Cellular and Molecular Physiology
https://www.readbyqxmd.com/read/26394389/regulation-of-peripheral-nerve-stimulation-technology
#5
REVIEW
Daniel M Birk, Dali Yin, Konstantin V Slavin
The number of peripheral nerve stimulation (PNS) indications, targets, and devices is expanding, yet the development of the technology has been slow because many devices used for PNS do not have formal regulatory approval. Manufacturers have not sought Food and Drug Administration (FDA) approval for PNS devices because of a perceived lack of interest amongst practitioners and patients. Without FDA approval, companies cannot invest in marketing to educate the implanters and the patients about the benefits of PNS in the treatment of chronic pain...
2015: Progress in Neurological Surgery
https://www.readbyqxmd.com/read/26237983/the-legal-and-regulatory-status-of-biosimilars-how-product-naming-and-state-substitution-laws-may-impact-the-united-states-healthcare-system
#6
Jordan Paradise
Alongside the constitutional controversy ultimately addressed by the Supreme Court, the colossal Patient Protection and Affordable Care Act (ACA) ushered in a new paradigm for regulation of biologics by the Food and Drug Administration (FDA). Nestled within the expansive ACA, the Biologics Price Competition and Innovation Act (BPCIA) set forth an abbreviated pathway to market for "biosimilar" and "interchangeable" biological products. While the current BPCIA implementation debate focuses chiefly on the scope of scientific and technical assessments by the FDA and the effect on the emergent biosimilar industry, two issues will prove essential for determinations of access to and costs of the resulting products: how the biosimilar and interchangeable biosimilar biologics are to be named, and whether pharmacist substitution is appropriate for products the FDA deems interchangeable...
2015: American Journal of Law & Medicine
https://www.readbyqxmd.com/read/25317866/the-fda-e-cigarettes-and-the-demise-of-combusted-tobacco
#7
Nathan K Cobb, David B Abrams
In April 2014, nearly 8 years after e-cigarettes were introduced into the U.S. market, the Food and Drug Administration (FDA) made a long-awaited announcement regarding its intention to regulate the devices, deeming them to be subject to regulation as tobacco products. The term "e-cigarette" (which..
October 16, 2014: New England Journal of Medicine
https://www.readbyqxmd.com/read/24340824/no-sisyphean-task-how-the-fda-can-regulate-electronic-cigarettes
#8
Jordan Paradise
The adverse effects of smoking have fostered a natural market for smoking cessation and smoking reduction products. Smokers attempting to quit or reduce consumption have tried everything: "low" or "light" cigarettes; nicotine-infused chewing gum, lozenges, and lollipops; dermal patches; and even hypnosis. The latest craze in the quest to find a safer source of nicotine is the electronic cigarette. Electronic cigarettes (e-cigarettes) have swept the market, reaching a rapidly expanding international consumer base...
2013: Yale Journal of Health Policy, Law, and Ethics
https://www.readbyqxmd.com/read/24166236/development-times-clinical-testing-postmarket-follow-up-and-safety-risks-for-the-new-drugs-approved-by-the-us-food-and-drug-administration-the-class-of-2008
#9
Thomas J Moore, Curt D Furberg
IMPORTANCE: The US Food and Drug Administration (FDA) has advanced multiple proposals to promote biomedical innovation by making new drugs available more quickly but with shorter, smaller, and more selective clinical trials and less rigorous end points. OBJECTIVE: To inform the debate about appropriate standards, we studied the development times, clinical testing, postmarket follow-up, and safety risks for the new drugs approved by the FDA in 2008, when most provisions of current law, regulation, and policies were in effect...
January 2014: JAMA Internal Medicine
https://www.readbyqxmd.com/read/23181572/from-bortezomib-to-other-inhibitors-of-the-proteasome-and-beyond
#10
REVIEW
Daniela Buac, Min Shen, Sara Schmitt, Fathima Rani Kona, Rahul Deshmukh, Zhen Zhang, Christine Neslund-Dudas, Bharati Mitra, Q Ping Dou
The cancer drug discovery field has placed much emphasis on the identification of novel and cancer-specific molecular targets. A rich source of such targets for the design of novel anti-tumor agents is the ubiqutin-proteasome system (UP-S), a tightly regulated, highly specific pathway responsible for the vast majority of protein turnover within the cell. Because of its critical role in almost all cell processes that ensure normal cellular function, its inhibition at one point in time was deemed non-specific and therefore not worth further investigation as a molecular drug target...
2013: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/22233294/pharmaceutical-industry-perspective-on-risk-evaluation-and-mitigation-strategies-manufacturer-take-heed
#11
REVIEW
Susan Nicholson, Janet Peterson, Behin Yektashenas
INTRODUCTION: Enactment of the Food and Drug Administration Amendments Act of 2007 (FDAAA) authorized the FDA to require manufacturers to submit Risk Evaluation and Mitigation Strategy (REMS) when it was deemed necessary to ensure that a drug's benefit outweigh its risk. REMS apply to new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologics license applications (BLAs). The objective of this review is to describe the impact of REMS requirements on the pharmaceutical industry...
March 2012: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/21321283/medical-device-recalls-and-the-fda-approval-process
#12
Diana M Zuckerman, Paul Brown, Steven E Nissen
BACKGROUND: Unlike prescription drugs, medical devices are reviewed by the US Food and Drug Administration (FDA) using 2 alternative regulatory standards: (1) premarket approval (PMA), which requires clinical testing and inspections; or (2) the 510(k) process, which requires that the device be similar to a device already marketed (predicate device). The second standard is intended for devices that the FDA deems to involve low or moderate risk. METHODS: We analyzed the FDA's high-risk List of Device Recalls from 2005 through 2009...
June 13, 2011: Archives of Internal Medicine
https://www.readbyqxmd.com/read/20559979/fda-s-perspectives-on-cardiovascular-devices
#13
REVIEW
Eric A Chen, Sonna M Patel-Raman, Kathryn O'Callaghan, Matthew G Hillebrenner
The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug & Cosmetic Act, Section 903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 http://www...
June 2009: Journal of Cardiovascular Translational Research
https://www.readbyqxmd.com/read/20528402/are-medicare-plans-complying-with-cms-regulation
#14
Joshua Cohen, Brian Young, Stephanie Rochon, Laura Faden
OBJECTIVES: The US Centers for Medicare and Medicaid Services (CMS) have put forth guidance recommending coverage of 75% of the costs of 'all or substantially all' drugs in six therapeutic categories deemed medically necessary for Medicare beneficiaries: anticonvulsants, antidepressants, antineoplastics, antipsychotics, HIV/AIDS and immunosuppressants. For 2007 filings, we analyzed compliance by 36 leading prescription drug plans with the CMS guidance. METHODS: Using databases at the Tufts Center for the Study of Drug Development, we identified 201 drugs approved by the US FDA between 1962 and 2007 in the six therapeutic categories mentioned above...
April 2008: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/19998744/export-of-pharmaceuticals-and-medical-devices-under-the-federal-food-drug-cosmetic-act-fda-s-striking-change-in-interpretation-post-shelhigh
#15
Edward M Basile, Deborah Tolomeo, Elizabeth Gluck
With no communication to industry except court filings in United States v. Undetermined Quantities of Boxes of Articles of Device (Shelhigh) and a draft guidance document, the Food and Drug Administration (FDA) has articulated new policies regarding export of pharmaceutical products and medical devices. FDA's departure from its historic interpretation of the export provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) significantly limits the ability of manufacturers to export misbranded drugs and medical devices that FDA deems "adulterated," contrary to the plain language and legislative intent of the FDCA...
2009: Food and Drug Law Journal
https://www.readbyqxmd.com/read/18677824/medical-devices-medical-device-reporting-baseline-reports-direct-final-rule
#16
(no author information available yet)
The Food and Drug Administration (FDA) is amending its medical device reporting regulations to remove a requirement for baseline reports that the agency deems no longer necessary. Currently, manufacturers provide baseline reports to FDA that include the FDA product code and the premarket approval or premarket notification number. Because most of the information in these baseline reports is also submitted to FDA in individual adverse event reports, FDA is removing the requirement for baseline reports. The removal of this requirement will eliminate unnecessary duplication and reduce the manufacturer's reporting burden...
June 13, 2008: Federal Register
https://www.readbyqxmd.com/read/18356646/food-and-drug-administration-s-perspectives-on-pediatric-cardiac-assist-devices
#17
Eric A Chen, Sonna M Patel-Raman, Michael R Berman, Bram D Zuckerman
Dual missions of the Center for Devices and Radiological Health at the Food and Drug Administration (FDA) are 1) promoting public health by promptly reviewing and taking appropriate, timely action regarding the marketing of regulated medical devices while at the same time, and 2) protecting public health by ensuring a reasonable assurance of the safety and effectiveness of medical devices deemed appropriate for human use. In the past, clinicians have used cardiac assist devices intended for adults to treat pediatric heart failure patients...
March 2008: ASAIO Journal: a Peer-reviewed Journal of the American Society for Artificial Internal Organs
https://www.readbyqxmd.com/read/16099105/evaluation-of-efficacy-of-heartworm-preventive-products-at-the-fda
#18
Victoria A Hampshire
The Center for Veterinary Medicine, U.S. Food and Drug Administration (FDA/CVM) has authority under the United States Code 21 under Section 514.80 to monitor for adverse experiences of approved animal products. Although veterinarians voluntarily report suspect drug-related events to manufacturers, firms that market FDA-approved animal products must report serious events to the FDA within 15 working days of the veterinarian or pet-owner's call to them. Under the present regulations, canine heartworm preventatives are approved for 100% efficacy after testing in laboratory and field conditions...
October 24, 2005: Veterinary Parasitology
https://www.readbyqxmd.com/read/15956239/fda-policy-on-unapproved-drug-products-past-present-and-future
#19
Renu Chhabra, Mary E Kremzner, Brenda J Kiliany
OBJECTIVE: To review the history of drug regulation by the Food and Drug Administration (FDA) as it relates to unapproved drugs and FDA policy, along with the FDA's efforts to avoid future incidents by amending and enforcing those policies that are already in place. DATA SOURCES: Data from FDA history documents, FDA guidances, Code of Federal Regulations Title 21, and presentations by the FDA's Office of Compliance were gathered. STUDY SELECTION AND DATA EXTRACTION: All information identified from the data sources was evaluated, and all information deemed relevant was included for this review...
July 2005: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/12814338/isotretinoin-use-and-subsequent-depression-and-suicide-presenting-the-evidence
#20
REVIEW
Peter R Hull, Carl D'Arcy
The growing number of reported cases of depression and suicide associated with isotretinoin (a retinoid receptor agonist) use in patients with acne has prompted concern among dermatologists, patients, and their relatives and has triggered new warnings from regulators including depression-related, patient-informed consent forms. In establishing a cause-effect relationship, it is useful to judiciously consider whether there is an association, what is the nature of that association, if there is a plausible biological mechanism of action, the validity and reliability of measures used and the strength of study designs...
2003: American Journal of Clinical Dermatology
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