OBSERVATIONS ON THE EVOLVING REGULATORY PROGRAMME OF TISSUE BANKING BY THE FOOD AND DRUG ADMINISTRATION IN THE USA

2002 ◽  
pp. 3-30
Author(s):  
ANDREI A. CZITROM
Keyword(s):  
Drug Administration ◽  
Tissue Banking ◽  
Food And Drug Administration ◽  
The Usa

scholarly journals Are we repeating mistakes of the past? A review of the evidence for esketamine

2020 ◽  
pp. 1-4 ◽  
Author(s):  
Mark A. Horowitz ◽  
Joanna Moncrieff
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
The Past ◽  
The Usa ◽  
Resistant Depression ◽  
Safety Signals

Summary Esketamine has been licensed for ‘treatment-resistant depression’ in the USA, UK and Europe. Licensing trials did not establish efficacy: two trials were negative, one showed a statistically significant but clinically uncertain effect, and a flawed discontinuation trial was included, against Food and Drug Administration precedent. Safety signals – deaths, including suicides, and bladder damage – were minimised.

scholarly journals Hearables: eLearning in the Workplace

2019 ◽  
pp. 97-102
Author(s):  
Rory McGreal
Keyword(s):  
Artificial Intelligence ◽  
Drug Administration ◽  
Hearing Aids ◽  
Hearing Aid ◽  
Food And Drug Administration ◽  
Personal Digital Assistant ◽  
Hearing Impaired ◽  
The Internet ◽  
Over The Counter ◽  
The Usa

Hearables, a term first coined by Hunn (2014), are wireless smart micro-computers with artificial intelligence that incorporate both speakers and microphones. They fit in the ears and can connect to the internet and to other devices; they are designed to be worn daily. These devices, such as the Bragi Dash, Vinci and Bose Hearphone are now appearing on the market, which is expected to exceed $40 billion in the USA by 2020 (Omnicom, 2018). Hearables are not headphones, nor hearing aids, nor ear plugs, although they could take on the affordances of any of these devices (Banks, 2018). Headphones are designed for listening to music. Hearing aids are designed as an aid for the hearing impaired. Ear plugs reduce unwanted sounds by cancelling noise. Hearables offer comparable features and additionally provide users with a microphone and connectivity to the internet supporting telephony and personal digital assistant (PDA) services (Computational Thinkers, n.d.). Prior to 2017, in the USA, such devices required the approval of the Food and Drug Administration. This approval is no longer required for hearables, as they are no longer considered to be medical hearing aids (Over the Counter Hearing Aid Act, 2017). This paves the way for the expansion in the market of significantly lower-priced hearables, undercutting the expensively-priced hearing aid market.

scholarly journals Underutilisation of no-tobacco-sale orders against retailers that repeatedly sell to minors, 2015–2019, USA

2021 ◽  
pp. tobaccocontrol-2020-056379
Author(s):  
Natalie Hemmerich ◽  
Desmond Jenson ◽  
Brice L Bowrey ◽  
Joseph G L Lee
Keyword(s):  
Content Analysis ◽  
Tobacco Control ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Smoking Prevention ◽  
Quantitative Content Analysis ◽  
Tobacco Products ◽  
Quantitative Content ◽  
The Family ◽  
The Usa

ImportanceResearch demonstrates that policies aimed at retailers who sell to minors must be strongly enforced to have an impact on youth usage rates.ObjectivesIn the USA, the Food and Drug Administration (FDA) conducts compliance checks, issues fines, and can order retailers to stop selling tobacco products (ie, no-tobacco-sale orders (NTSOs)) to enforce the Family Smoking Prevention and Tobacco Control Act. We sought to assess FDA’s utilisation of NTSOs.MethodsWe conducted a quantitative content analysis of FDA’s enforcement actions for inspections decided between 1 October 2015 and 29 March 2019. From the 536 134 inspection records we identified 148 NTSOs and 249 720 unique retailer locations, of which 2095 had three or more violations. We randomly sampled NTSOs (n=76) and retail locations (n=152) with frequent violations. We calculated the proportion of NTSOs that could have been issued earlier by FDA. We then calculated the proportion of retailers that could have been issued an NTSO, and the proportion actually issued an NTSO using FDA’s approach and a more stringent approach.ResultsAmong NTSOs, 94.7% (95% CI: 89.8% to 97.4%) of NTSOs could have been issued earlier under a more stringent approach. On average, when an NTSO could have been issued earlier, it could have been issued 453 days earlier (95% CI: 418 to 489; range: 89–1159). Among frequently violating retail locations, 73.6% (95% CI: 66.0% to 80.0%) were eligible for an NTSO. Of those, 1.9% (95% CI: 0.5% to 7.0%) had received an NTSO.ConclusionsThe FDA’s failure to fully leverage its powers to address retailers’ underage sales of tobacco products has weakened efforts to curb the youth e-cigarette epidemic.

The chemotherapy of psoriasis with azaribine: Mirage or miracle

1991 ◽  
Vol 56 (5) ◽  
pp. 945-953 ◽  
Author(s):  
William Drell ◽  
Jan Škoda ◽  
Arnold D. Welch
Keyword(s):  
Drug Administration ◽  
Mechanism Of Action ◽  
Food And Drug Administration ◽  
Severe Psoriasis ◽  
Clinical Use ◽  
The Usa ◽  
Symptoms And Signs

An antimetabolite, administered orally, which alleviates the symptoms and signs of severe psoriasis, azaribine (triacetyl-6-azauridine), was approved by the Food and Drug Administration (FDA of the USA) for clinical use in 1975, but 18 months later approval was withdrawn. The mechanism of action of azaribine (as a precursor of 6-azauridine 5’-azauridine 5’-monophosphate) is described and the probable cause of the infrequent vascular thromboses and a means of preventing them (by the co-administration of pyridoxine) are discussed.

scholarly journals The Institute of Medicine, the Food and Drug Administration, and the calcium conundrum

2014 ◽  
Vol 17 (8) ◽  
pp. 1865-1867 ◽  
Author(s):  
Shristi Neupane ◽  
Stephen J Knohl
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Age Group ◽  
Institute Of Medicine ◽  
Over The Counter ◽  
Health And Nutrition ◽  
Upper Limit ◽  
Diet Supplements ◽  
Us Government ◽  
The Usa

AbstractIn the present article we aim to bring forward the apparent disconnect between two US government-sponsored entities – the Institute of Medicine (IOM) and the Food and Drug Administration (FDA) – regarding the safe upper limit of Ca intake.In light of the 2011 US Congress-appointed IOM report indicating an upper limit of elemental Ca intake of 2000–2500 mg/d in adults (based on age group), it is perplexing that the FDA has not yet required a change on the labelling of over-the-counter Ca-containing antacids, some of which indicate an upper limit of elemental Ca intake of 2800–3000 mg/d. Even more concerning is that Ca intake is rarely from supplementation in isolation. National Health and Nutrition Examination Survey (NHANES) data from 2003–2006 indicate that mean dietary Ca intakes for males ranged from 871 to 1266 mg/d and for females from 748 to 968 mg/d depending on the age group. The estimated total Ca (diet + supplements) intake exceeded the upper limit in 5 % of the population older than 50 years. Furthermore, NHANES data from 1999–2000 indicate that when Ca is taken as part of an antacid preparation, patients often fail to report this as Ca intake. Thus, individuals taking the maximum allowable dose of supplemental Ca as antacids are at high risk for complications associated with excess Ca intake.Our hope is that by describing Ca homeostasis and highlighting the risks and dangers of Ca overload, the FDA will align its recommendation with the IOM and solve the current Ca conundrum in the USA for the sake of patient safety.

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