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Our Guide to “ Pre-Approval ” Access to Drugs For Both Doctors & Patients
By ALISON-BATEMAN HOUSE
Patients (and physicians) trying to access an unapproved drug outside of a clinical trial can feel as though they’re navigating uncharted waters. Many physicians don’t know that the FDA permits the use of unapproved drugs outside of clinical trials; those who do know often have no idea how to access such drugs for their patients. Those physicians who know about pre-approval access are largely specialists in certain areas—often, oncology or rare diseases—and they are generally self-taught: they didn’t learn about pre-approval access in medical school or in their residencies. Thus, while som...
Source: The Health Care Blog - September 6, 2017 Category: Consumer Health News Authors: John Irvine Tags: Uncategorized 21st Century Cures Act Clinical Trials Compassionate Use Expanded Access FDA Pre-Approval Drugs Source Type: blogs
Our Guide to Pre-Approval Access to Drugs For Both Doctors & Patients
By ALISON-BATEMAN HOUSE
In April 2016, I published guidance, in the form of a mock case study, on how to access a drug before it has been approved by the FDA—what’s known as pre-approval (or expanded or compassionate) access. This is an updated version of that guidance, reflecting multiple important changes in the pre-approval landscape over the past year. In particular, the FDA rolled out a new, streamlined form for single-patient requests, and Congress passed the 21st Century Cures Act, which, among many other things, mandated that certain pharmaceutical companies provide public information about their pre-approval ...
Source: The Health Care Blog - September 6, 2017 Category: Consumer Health News Authors: John Irvine Tags: Uncategorized 21st Century Cures Act Clinical Trials Compassionate Use Expanded Access FDA Pre-Approval Drugs Source Type: blogs
Grey literature: An important resource in systematic reviews
Abstract
Systematic reviews aid the analysis and dissemination of evidence, using rigorous and transparent methods to generate empirically attained answers to focused research questions. Identifying all evidence relevant to the research questions is an essential component, and challenge, of systematic reviews. Grey literature, or evidence not published in commercial publications, can make important contributions to a systematic review. Grey literature can include academic papers, including theses and dissertations, research and committee reports, government reports, conference papers, and ongoing research, among others. It...
Source: Journal of Evidence-Based Medicine - December 21, 2017 Category: General Medicine Authors: Arsenio Paez Tags: METHODOLOGY Source Type: research
Yellow fever: laboratorial diagnosis and clinical manifestations
ABSTRACT Yellow fever is an infectious disease of acute evolution, initially non-contagious, transmitted by a ribonucleic acid (RNA) virus that belongs to the Flaviviridae family. In the period from December 2016 until March 17, 2017, 1, 561 suspected cases of wild yellow fever were reported to the Ministry of Health in Brazil. Among these cases, 850 (54.8%) remain under investigation, 448 (28.7%) were confirmed and 263 (16.9%) were discarded. Out of the total cases reported, 264 died, 144 (54.5%) were confirmed for the disease, 110 (41.7%) were investigated and 10 (3.8%) were discarded. The case fatality rate among confir...
Source: Jornal Brasileiro de Patologia e Medicina Laboratorial - December 12, 2018 Category: Pathology Source Type: research
Fight Aging! Newsletter, March 25th 2019
This study defines a new clinically relevant concept of T-cell senescence-mediated inflammatory responses in the pathophysiology of abnormal glucose homeostasis. We also found that T-cell senescence is associated with systemic inflammation and alters hepatic glucose homeostasis. The rational modulation of T-cell senescence would be a promising avenue for the treatment or prevention of diabetes.
Intron Retention via Alternative Splicing as a Signature of Aging
https://www.fightaging.org/archives/2019/03/intron-retention-via-alternative-splicing-as-a-signature-of-aging/
In recent years researchers have inv...
Source: Fight Aging! - March 24, 2019 Category: Research Authors: Reason Tags: Newsletters Source Type: blogs
Urgent need for government and social policies to prevent suicide in Brazil
Source: Jornal Brasileiro de Psiquiatria - May 8, 2020 Category: Psychiatry Source Type: research
Recommendations Of The Brazilian Society Of Nephrology Regarding Pediatric Patients On Renal Replacement Therapy During The Covid-19 Pandemic.
We present the recommendations of the Brazilian Society of Nephrology regarding the treatment of pediatric patients with kidney diseases during the COVID-19 pandemic.
METHODS: Articles and documents from medical societies and government agencies on specific recommendations for children on RRT in relation to COVID-19 as well as those focused on epidemiological aspects of this condition in Brazil Were evaluated and analyzed.
RESULTS: We present recommendations on outpatient care, transportation to dialysis centers, peritoneal dialysis, hemodialysis, and kidney transplantation in children and adolescents during the CO...
Source: Jornal Brasileiro de Nefrologia - September 4, 2020 Category: Urology & Nephrology Tags: J Bras Nefrol Source Type: research
Are Social Media Companies Common Carriers?
Matthew FeeneyDuring Donald Trump ’s presidency, many Republican lawmakers and conservative activists took steps to address perceived anti‐conservative bias in “Big Tech.” The most prominent of these efforts fit into two categories: proposed amendments to Section 230 and executive branch action. More recently, legal schol ars, policy analysts, and one Supreme Court justice have considered a third option—common carriage regulation—as a means to force prominent social media companies to host more speech. Such an approach would require these social media companies to treat all legal content equally and refrai...
Source: Cato-at-liberty - May 24, 2021 Category: American Health Authors: Matthew Feeney Source Type: blogs
Acute kidney injury and renal replacement therapy: terminology standardization
J Bras Nefrol. 2022 May 18:S0101-28002022005027401. doi: 10.1590/2175-8239-JBN-2021-0284en. Online ahead of print.ABSTRACTThe Department of Acute Kidney Injury (IRA) of the Brazilian Society of Nephrology prepared this document for the purpose of standardizing AKI terminology and dialysis modalities in the Portuguese language for Brazil. Several terms with similar meanings have been used in AKI and its dialysis modalities, causing confusion and disparities among patients, nephrologists, health institutions, private care companies, insurance companies and government entities. These disparities can impact medical care, hospi...
Source: Jornal Brasileiro de Nefrologia - May 17, 2022 Category: Urology & Nephrology Authors: Thiago Reis Vinicius Sard ão Colares Eduardo Rocha Mauricio Younes-Ibrahim Emerson Quintino de Lima Lucia da Concei ção Andrade Daniela Ponce Jos é H Rocco Suassuna Luis Yu Source Type: research
Positive topline phase III results show Roche ' s Vabysmo improved vision for people living with retinal vein occlusion (RVO)
Vabysmo achieved its primary endpoint of non-inferiority toaflibercept in RVO in the BALATON and COMINO clinical trialsVabysmo was generally well tolerated, with a safety profile consistent with previous trialsVabysmo is the first and only treatment that targets and inhibits two disease pathways involving Ang-2 and VEGF-A, linked to a number of vision-threatening retinal conditionsDetailed results will be presented at an upcoming medical meeting and submitted to regulatory authorities around the worldBasel, 27 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from two global phase I...
Source: Roche Media News - October 27, 2022 Category: Pharmaceuticals Source Type: news
