Food and Drug Administration (FDA) Blogs This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Ethics of Placebo Controls in Coronavirus Vaccine Trials
Multiple candidate vaccines for coronavirus are being evaluated scientifically in a process of unprecedented speed, and thousands of individuals around the world have volunteered to participate in placebo-controlled phase III field trials. If, or when, one of these candidate vaccines is proved to be safe and effective and receives an emergency use authorization by the Food and Drug Administration, will it continue to be ethical to enroll participants in other coronavirus trials that randomize half of them to a placebo? The post Ethics of Placebo Controls in Coronavirus Vaccine Trials appeared first on The Hastings Center....
Source: blog.bioethics.net - October 27, 2020 Category: Medical Ethics Authors: Susan Gilbert Tags: Health Care Clinical Trials & Research Ethics Covid vaccine trials COVID-19 Hastings Bioethics Forum syndicated Source Type: blogs

Cures for Cerumen Impaction
Cerumen impaction removal may not be considered an emergent procedure in the emergency department, but this omnipresent natural phenomenon will bring patients, from infants to the elderly, to your department at all hours of the day and night because loss of hearing is a foreign and uncomfortable sensation.Cerumen impaction can cause complete hearing loss, pain, dizziness, chronic cough, and even infection. Patients who attempt to remove cerumen at home can end up with otitis externa or otitis media and even tympanic membrane trauma. The cerumen can block visualization of the tympanic membrane so TM rupture or ear infect...
Source: The Procedural Pause - October 1, 2020 Category: Emergency Medicine Tags: Blog Posts Source Type: blogs

How can we improve the quality of medications?
Do you know what it ’s like to sit in a meeting and learn that something you hold close as a fundamental principle is probably not as fundamentally true as you thought? That’s the way I felt earlier this week while attending a meeting on the quality of pharmaceuticals, sponsored by the Food and Drug Administration and Duke University’s […]Find jobs at Careers by KevinMD.com. Search thousands of physician, PA, NP, and CRNA jobs now. Learn more. (Source: Kevin, M.D. - Medical Weblog)
Source: Kevin, M.D. - Medical Weblog - September 30, 2020 Category: General Medicine Authors: < span itemprop="author" > < a href="https://www.kevinmd.com/blog/post-author/j-leonard-lichtenfeld" rel="tag" > J. Leonard Lichtenfeld, MD < /a > < /span > Tags: Meds Medications Source Type: blogs

" It's the Rx rebates, stupid! "
Although mylast post addressed one realistic solution to an embedded problem in the U.S. healthcare system related to prescriptions of life-sustaining essentials like insulin (which isn ' t a NEW drug; it was discovered in 1921), the problem has never really been explained which is necessary when interacting with lawmakers about potential legislative solutions to the problem of runaway insulin prices. So, this post aims to be an explainer. Insulin is today a prescription medicine (it used to be OTC) and there are only a handful of manufacturers worldwide. That is the root of the problem, but not due to a lack of competitio...
Source: Scott's Web Log - September 29, 2020 Category: Endocrinology Tags: Food and Drug Administration Drug Channels FDA insulin legislation price caps price-caps rebate reform rebates Source Type: blogs

" It's the Rx rebates, stupid! "
Although mylast post addressed one realistic solution to an embedded problem in the U.S. healthcare system related to prescriptions of life-sustaining essentials like insulin (which isn ' t a NEW drug; it was discovered in 1921), the problem has never really been explained which is necessary when interacting with lawmakers about potential legislative solutions to the problem of runaway insulin prices. So, this post aims to be an explainer. Insulin is today a prescription medicine (it used to be OTC, and early-generations still are, but with the advent of analog insulin, the drug companies persuaded the FDA to reclassi...
Source: Scott's Web Log - September 29, 2020 Category: Endocrinology Tags: Food and Drug Administration Drug Channels FDA insulin legislation price caps price-caps rebate reform rebates Source Type: blogs

Too much licorice may kill you
This morning, thanks to a friend’s post on Facebook, I read an Associated Press article, picked up and published by NBC News, that REALLY shocked me. Here’s the link: https://www.nbcnews.com/news/us-news/daily-black-licorice-habit-kills-massachusetts-construction-worker-n1240902?fbclid=IwAR1kiMGaCEQGdDrGjyVkkdy1l0MT8nNSAByFBnzqdYQFxkqYGAuQIjNgrcM Is it possible for someone to DIE from eating too much licorice??? The incredible answer is…yes. It happened to a 54-year-old man in Massachusetts, U.S.A. He had been eating A LOT of licorice, a bag and a half apparently!!!, every day for a few weeks before he co...
Source: Margaret's Corner - September 25, 2020 Category: Cancer & Oncology Authors: Margaret Tags: Blogroll death licorice. glycyrrhizic acid Source Type: blogs

Statement of Support for the FDA
The Working Group on Compassionate Use and Preapproval Access (CUPA), a project of the NYU Grossman School of Medicine Division of Medical Ethics The undersigned are members of a multidisciplinary group comprising bioethicists, clinicians, patient advocates, and representatives from industry and law who for the past seven years have been studying the ethical issues surrounding access to medical products before they have received regulatory approval. We support the U.S. Food and Drug Administration (FDA) as an institution and are concerned that its dedicated staff are facing a historically unprecedented threat ...
Source: blog.bioethics.net - September 12, 2020 Category: Medical Ethics Authors: Blog Editor Tags: Featured Posts Health Regulation & Law Human Subjects Research & IRBs Pharmaceuticals Uncategorized FDA Source Type: blogs

Whom Can We Trust? COVID-19, Politics, and the Decay of Federal Science
by Craig Klugman, Ph.D. Since 1927, the agency now known as the Food and Drug Administration became the federal agency responsible for the safety of food for human consumption, drugs, and therapeutic devices. Started in 1946, the Centers for Disease Control & Prevention opened to fight communicable diseases (starting with malaria) in the U.S. and around the world. Together, these two agencies are among the most respected scientific institutions in the world. At least they were until the last few weeks. On August 23, FDA commissioner Stephen Hahn announced emergency a...
Source: blog.bioethics.net - September 3, 2020 Category: Medical Ethics Authors: Craig Klugman Tags: Featured Posts Institutions, Centers, Funding Politics Public Health #covid19 #diaryofaplagueyear COVID-19 Source Type: blogs

Leveraging the COVID Pandemic to Advance Vapophobia
Jeffrey A. SingerThere isno link between nicotine in e ‐cigarettes and E‐cigarette of Vaping Product‐Use Associated Lung Injury (EVALI). EVALI cases have been traced tovitamin E acetate, used as a solvent for THC in black market vaping products. Flavored vaping products arepreferred by adults who switch from combustible tobacco smoking to vaping. Yet none of these facts prevented a federal ban on flavored vaping products from going into effect last February. Not satisfied with a ban on flavored products, vaping opponents are now trying to leverage fear of COVID-19 infection as a mean...
Source: Cato-at-liberty - August 17, 2020 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

Illicit Trade Poses No Threat to an FDA Rule to Minimize Nicotine in Smoked Tobacco Products
Eric Lindblom (Georgetown Law), Illicit Trade Poses No Threat to an FDA Rule to Minimize Nicotine in Smoked Tobacco Products, 109 (7) AJPH 960 (2019): A US Food and Drug Administration (FDA) rule setting nicotine limits for cigarettes and similarly... (Source: HealthLawProf Blog)
Source: HealthLawProf Blog - August 12, 2020 Category: Medical Law Authors: Katharine Van Tassel Source Type: blogs

Crimes against humanity
My electricity has been out since Tuesday, and due to the utter indifference and incompetence of our electric company, Eversource, I probably won ' t get it back till next Tuesday. But that ' s not the crime against humanity. Blogging will have to be light nevertheless, because I can only charge up my devices at my neighbor ' s house -- who have a generator -- and then I need to ration my computer use.In any case, in addition to the utter blithering idiocy and downright deliberate mass murder that constitutes the Resident ' s disastrous failure to mitigate the Covid-19 pandemic -- and I don ' t need to go over that a...
Source: Stayin' Alive - August 7, 2020 Category: American Health Source Type: blogs

Zombie lies eat my brain
Hydroxychloroquine flunks Phase III trial in mild-to-moderate Covid-19The study adds to the growing body of evidence that the drug, promoted early in the pandemic by President Trump, is ineffective, despite its getting a briefly renewed lease on life earlier this month thanks to a retrospective analysis. Results of new clinical trial published late last week have found that hydroxychloroquine – the malaria and autoimmune disease drug that President Donald Trump promoted as a potential “game changer” early in the Covid-19 pandemic – not only failed to improve outcomes in those with mild-to-moderate diseas...
Source: Stayin' Alive - July 27, 2020 Category: American Health Source Type: blogs

A new hormonal therapy for prostate cancer is under expedited FDA review
In June, the US Food and Drug Administration (FDA) launched an accelerated review of a promising new drug for advanced prostate cancer. Called relugolix, it suppresses testosterone and other hormones that speed the cancer’s growth. If approved, this new type of hormonal therapy is expected to set a new standard of care for the disease. Doctors give hormonal therapies when a man’s tumor is metastasizing (spreading beyond the prostate), or if his PSA levels start rising after surgery or radiation. The most commonly used hormonal therapies, called LHRH agonists, will eventually lower testosterone levels in blood. ...
Source: Harvard Health Blog - July 13, 2020 Category: Consumer Health News Authors: Charlie Schmidt Tags: Health Prostate Knowledge Treatments HPK Source Type: blogs

FDA Should Help Defeat Another Viral Epidemic —HIV—By Reclassifying PrEP And PEP Over The Counter
Jeffrey A. SingerLast October, California expanded the scope of practice of pharmacists to allow them toprescribe HIV pre ‐exposure prophylaxis (PrEP) and post‐exposure prophylaxis (PEP) to people at risk.Similar legislation is currently being considered by the New York state legislature.I have arguedhere that the Food and Drug Administration should reclassify PrEP and PEP as over the counter. While allowing pharmacists to prescribe PrEP and PEP is a step in the right direction, it would greatly improve access to the drugs for people at risk if they were available OTC. They can then be sold in reta...
Source: Cato-at-liberty - July 9, 2020 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

The “Drug Czar” Says Overdose Deaths Were Already Rising Before Pandemic and Now Are Spiking—The Ultimate Blame Belongs to Prohibition
Jeffrey A. SingerWhite House “drug czar” Jim Carroll toldPolitico earlier this week that an Office of National Drug Control Policy analysis finds an 11.4 percent year ‐over‐year increase in opioid‐related overdose deaths during the first four months of 2020. Kentucky has seen a 25 percent increase in overdose deaths during the first four months of this year, and West Virginia saw a 50 percent increase in deaths since the beginning of the year. The data are incomplete at this point, and not all states have reported in.Mr. Carroll attributed much of the increase in the overdose rate to anxie...
Source: Cato-at-liberty - July 1, 2020 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs