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.

FDA releases first Artificial Intelligence (AI) regulatory plan to promote responsible digital health innovation
FDA Releases Artificial Intelligence/Machine Learning Action Plan (FDA press release): Today, the U.S. Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan describes a multi-pronged approach to advance the Agency’s oversight of AI/ML-based medical software … The AI/ML-Based Software as a Medical Device Action Plan outlines five actions that the FDA intends to take, including: Further developing the proposed regulatory framework, including through issuance of draft guidance on a predetermined c...
Source: SharpBrains - January 25, 2021 Category: Neuroscience Authors: SharpBrains Tags: Brain/ Mental Health Technology & Innovation artificial intelligence digital health digital health innovation FDA Food and Drug Administration machine-learning regulatory framework software Source Type: blogs

A Review of Research into Intermittent Fasting and its Effects on Longevity
Intermittent fasting (such as alternate day fasting) is not as effective as calorie restriction (consistent reduction in calories every day) in extending life span in animal models such as mice, but it does have many of the same effects on health and longevity. Even when total calorie intake is held consistent between intermittent fasting animals and controls, there are still benefits that accrue to the fasting animals. One might conclude that time spent in a state of hunger, with all of the signaling and changes in cell behavior that comes with it, is a meaningful component of the benefits derived from calorie restriction...
Source: Fight Aging! - January 21, 2021 Category: Research Authors: Reason Tags: Daily News Source Type: blogs

Neurostimulation device GammaSense by Cognito Therapeutics secures FDA Breakthrough Device Designation to explore Alzheimer ’s Disease applications
Credit: The Picower Institute @ MIT Cognito Therapeutics nets FDA breakthrough label for light, sound therapy for Alzheimer’s disease (Fierce Biotech): Using specific frequencies of flashing lights and sounds to stimulate the brain’s electrical activity, Cognito Therapeutics believes it can help treat Alzheimer’s disease by energizing neurons and reactivating the immune system. Described as similar to a strobe light, but much faster, Cognito’s GammaSense stimulation system is built into a pair of opaque glasses worn with a set of headphones. The daily treatment has shown positive effects in mice, with changes in t...
Source: SharpBrains - January 14, 2021 Category: Neuroscience Authors: SharpBrains Tags: Brain/ Mental Health Technology & Innovation amyloid plaques breakthrough device breakthrough therapy cognitive-symptoms Cognito Therapeutics digital therapeutics FDA GammaSense hippocampus neurodegenerative-diseases neuromodulatio Source Type: blogs

Fight Aging! Newsletter, January 11th 2021
This study demonstrates the potential of a natural (o-Vanillin) and a synthetic (RG-7112) senolytic compounds to remove senescent IVD cells, decrease SASP factors release, reduce the inflammatory environment and enhance the IVD matrix production. Removal of senescent cells, using senolytics drugs, could lead to improved therapeutic interventions and ultimately decrease pain and a provide a better quality of life of patients living with intervertebral disc degeneration and low back pain. From Ying Ann Chiao of Oklahoma Medical Research Foundation: Mitochondrial dysfunction plays a central role in aging and cardiovasc...
Source: Fight Aging! - January 10, 2021 Category: Research Authors: Reason Tags: Newsletters Source Type: blogs

An Update on Progress at Tissue Engineering Company Lygenesis
The development programs conducted at Lygenesis came about as a result of an academic researcher who followed up on the realization that the positioning of some organs in the body is arbitrary. Much of the function of organs like the liver and the thymus could be carried out in any location that is well-supplied with blood and easily accessible to roving cells. The liver is a chemical factory, producing and consuming various proteins and metabolites. The thymus is a cell factory; thymocytes migrate to the organ from the bone marrow, and once there are transformed into T cells of the adaptive immune system via their interac...
Source: Fight Aging! - January 4, 2021 Category: Research Authors: Reason Tags: Longevity Industry Source Type: blogs

The Great Bucatini Shortage of 2020 and the FDA ’s History of Telling Italians How to Make Italian Food
Michael F. CannonRachel Handler has a delightfulpiece atNew Yorkmagazine ’s food and restaurant blogGrub Street on how Big Pasta is using government regulation to punish competitors and consumers. The result is that the U.S. Food and Drug Administration, in addition to causing a shortage of COVID-19diagnostic tests andvaccines, is basically causing a nationwide shortage of bucatini.On March 30, at the beginning of a pandemic whose supply shocks were making everything from toilet paper to pasta harder to get, the FDAblocked imports of De Cecco bucatini. The FDA found the iron content of the Italian company’s bu...
Source: Cato-at-liberty - December 30, 2020 Category: American Health Authors: Michael F. Cannon Source Type: blogs

A heartfelt thanks to the COVID-19 vaccine trial volunteers
We officially now have the vaccine and have begun to immunize the frontline workers at our hospital with the COVID-19 vaccine. And since the U.S. Food and Drug Administration (FDA) has granted the Pfizer/BioNTech vaccine emergency use authorization and a second vaccine from Moderna, there’s more hope for an end to the global pandemic. This specific batch of […]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 - December 20, 2020 Category: General Medicine Authors: < span itemprop="author" > < a href="https://www.kevinmd.com/blog/post-author/karen-tran-harding" rel="tag" > Karen Tran-Harding, MD < /a > < /span > Tags: Conditions COVID-19 coronavirus Infectious Disease Source Type: blogs

Discarding Precious Vaccine Can Be an Unintended Side Effect of Regulation
Jeffrey A. SingerSeveral doses of Pfizer ’s new mRNA COVID vaccine were wasted when pharmacists noted that many of the vials of vaccine, intended to contain five doses, had enough left over vaccine for one or two additional doses. Because the product description on page 3 of the Food and Drug Administration ’sEmergency Use Authorization for the vaccine stated that each vial, upon dilution, contains five doses of vaccine, many pharmacists were uncertain if the regulatory agency permitted them to use any residual vaccine in the vial. It is not unusual for manufacturers to add a little extra to th...
Source: Cato-at-liberty - December 17, 2020 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

Top 10 Online Medical Resources For The Patients Of The Future
There are over 1 billion health-related searches on Google every single day, according to a report. This was about 7% of all searches on the platform before, and no one will be surprised when the 2020 data massively surpasses this number. After all, the internet is likely the first source to turn to with your health-related questions. But which hits are relevant, and which lead to straightforward la la land – even with the best intentions and the best A.I. toolset, the search giant can’t exclude the latter from among the results. And yet, doing so is especially important in the case of medicine and healthcare, s...
Source: The Medical Futurist - December 10, 2020 Category: Information Technology Authors: berci.mesko Tags: Digital Health Research E-Patients Medical Education Medicine social media Webicina webmd gc2 online resources pharmaceutics Topol Mayo Clinic ePatients Medscape Eric Topol Smart Patients Medline Plus National Library of Source Type: blogs

“Drug Lag” and the COVID Vaccine
Jeffrey A. SingerThe U.K ’s Medicines and Healthcare products Regulatory Agency (MHRA)announced this morning that it has approved the Pfizer/ BioNTech COVID vaccine and expects to begin immunizing its population within a week. This vaccine, along with one independently developed by Moderna Pharmaceuticals, are the first evermRNA vaccines, which use a newprocess that can potentially be used against other infectious diseases and even to treat or preventcancer. Clinical trials show both of these vaccines to be95 percent effective. They also have an excellentsafety profile thus far —in part because they don’...
Source: Cato-at-liberty - December 2, 2020 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

Questionable “Alzheimer’s blood test” goes on sale prior to FDA approval
First blood test to help diagnose Alzheimer’s goes on sale (NBC News): A company has started selling the first blood test to help diagnose Alzheimer’s disease, a leap for the field that could make it much easier for people to learn whether they have dementia. It also raises concern about the accuracy and impact of such life-altering news. Independent experts are leery because key test results have not been published and the test has not been approved by the U.S. Food and Drug Administration — it’s being sold under more general rules for commercial labs. The test is not intended for general screening or for people w...
Source: SharpBrains - December 1, 2020 Category: Neuroscience Authors: SharpBrains Tags: Brain/ Mental Health Alzheimer's blood test Alzheimer’s Disease amyloid amyloid buildup amyloid hypothesis blood-test dementia FDA Food and Drug Administration Source Type: blogs

FDA grants clearance for NightWare app designed to reduce PTSD-related nightmares
FDA grants De Novo clearance to prescription Apple Watch app for nightmare disorder (MobiHealth News): The FDA granted Minneapolis-based NightWare a De Novo clearance on Friday for its Apple Watch and iPhone app designed to improve the sleep quality of those experiencing nightmare disorder and nightmares related to PTSD. The digital therapeutic – which received breakthrough designation from the agency last year – uses the Watch’s sensors to track the heart rate and movement of users as they sleep. After establishing a baseline profile for the patient within one or two nights’ sleep, the machine learning algorithm s...
Source: SharpBrains - November 16, 2020 Category: Neuroscience Authors: SharpBrains Tags: Brain/ Mental Health Technology & Innovation Apple Watch De Novo clearance digital therapeutic FDA heart-rate iPhone app machine-learning nightmares NightWare prescription PTSD sleep quality Source Type: blogs

Vaccine Music To Libertarian Ears
Ryan BourneRonald Reagan once said,“There is no limit to the amount of good you can do if you don’t care who gets the credit.” In the U.S.’s fraught political climate, sadly it was predictable that even the welcome news of Pfizer’s promising COVID-19 trial results would produce a political dogfight about the timing of the announcement and who should be thanked for the prospect of the pandemic ending sooner.Vice President Mike Pence, for example, tweeted this morning: “HUGE NEWS: Thanks to the public‐private partnership forged by President@realDonaldTrump,@pfizer announced its Coronavirus Vaccine trial...
Source: Cato-at-liberty - November 9, 2020 Category: American Health Authors: Ryan Bourne Source Type: blogs

Breaking my rule
As I often say here, I try avoid making predictions, especially about the future. (Yes, highly original.) However, to the extent I have relevant expertise and there is good enough information to fit into the model, it is sometimes helpful. Joe Biden will assume the presidency on January 20 confronting enormous problems. Right now, it ' s conceivable that Democrats will effectively control the Senate, which would make a huge difference, but that will require winning two head-to-head Senate races in Georgia. That seems a less than 50/50 bet, but without the Dumpster on the ticket it ' s hard to say how motivated G...
Source: Stayin' Alive - November 6, 2020 Category: American Health Source Type: blogs

Ethics of Emergency Use Authorization During the Pandemic
The Food and Drug Administration's rigorous guidance for an emergency use authorization of a Covid vaccine was met by resistance from the White House, since some of the terms would make it virtually impossible to issue a vaccine-related emergency authorization before Election Day. Understanding the ethical dimensions of issuing it for a vaccine can provide clarity on the necessity of the FDA’s stringent guidelines. The post Ethics of Emergency Use Authorization During the Pandemic appeared first on The Hastings Center. (Source: blog.bioethics.net)
Source: blog.bioethics.net - October 30, 2020 Category: Medical Ethics Authors: Susan Gilbert Tags: Health Care COVID-19 emergency use authorization Food and Drug Administration Hastings Bioethics Forum Health and Health Care syndicated White House Source Type: blogs