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.

Cardiomyopathy in muscular dystrophies
Important muscular dystrophies due to mutations in structural cytoskeletal dystrophin gene are known as dystrophinopathies. They include Duchenne muscular dystrophy, Becker muscular dystrophy and X-linked dilated cardiomyopathy. Primary presentation of most dystrophinopathies is skeletal muscle weakness. Duchenne muscular dystrophy is caused by mutations leading to absence of functional dystrophin. Becker muscular dystrophy is due to mutations resulting in reduced amounts of shortened dystrophin protein. Cardiac muscle being a striated muscle, is affected in many types of muscular dystrophies. Cardiomyopathy would contrib...
Source: Cardiophile MD - August 30, 2022 Category: Cardiology Authors: Johnson Francis Tags: General Cardiology Source Type: blogs

Digital therapeutics pioneer Akili Interactive Labs goes public, raising $150M+; trades down 49% first day
Akili Interactive is the latest company to go public via SPAC deal (Boston Business Journal): Boston’s Akili Interactive Labs Inc. is the latest Massachusetts-based company to go public after completing a reverse merger — in a year of market turmoil that saw few local firms passing the threshold between private and public status. Shares of Akili started trading on Monday on the Nasdaq Capital Market under the new ticker symbol “AKLI” after the company completed its previously announced reverse merger with Social Capital Suvretta Holdings Corp. I (Nasdaq: DNAA), a special purpose acquisition company, or SPAC. From t...
Source: SharpBrains - August 23, 2022 Category: Neuroscience Authors: SharpBrains Tags: Brain/ Mental Health Technology & Innovation Akili Interactive Labs AKLI cognitive Cognitive-impairment digital medicine digital therapeutics DNAA EndeavorRx neuropsychiatric neuropsychiatric diseases SPAC Source Type: blogs

Weekly Overseas Health IT Links –20th August 2022.
Here are a few I came across last week.Note: Each link is followed by a title and few paragraphs. For the full article click on the link above title of the article. Note also that full access to some links may require site registration or subscription payment-----https://www.digitalhealth.net/2022/08/ai-predictive-trial-staffordshire-hn-reduce-ae-admissions/AI predictive trial in Staffordshire reduces A&E admissions by 35%A trial which looked at how existing patient data could be used to predict those most likely to need hospital care has led to a 35% reduction on average in A&E attendances across Staffordshire.Jor...
Source: Australian Health Information Technology - August 20, 2022 Category: Information Technology Authors: Dr David G More MB PhD Source Type: blogs

DIY Blood Draw – Could Patients Collect Blood At Home?
Blood draws are essential, but this doesn’t make them anyone’s favourite pastime: they are time-consuming and involve needles. Is there a way to make it in a do-it-yourself (DIY) fashion? Can we collect blood samples at home? While this method will be far from omnipotent for the unforeseeable future, it might have its merits. The pandemic highlighted how avoiding contact with a large number of random patients can be a wise idea. Besides, home-sampling of blood can provide a very efficient and convenient method for clinical trials, encouraging patient participation. Let’s see the technology first. The init...
Source: The Medical Futurist - August 18, 2022 Category: Information Technology Authors: Andrea Koncz Tags: TMF E-Patients Future of Medicine blood test blood draw at-home tests at-home lab tests DIY blood draw blood sample at-home blood test at-home blood draw DIY blood test blood work Source Type: blogs

FDA Finally Improves Access to Hearing Aids for SOME People
Jeffrey A. SingerToday the Food and Drug Administration issued a final rule which will give millions of Americans over ‐the‐counter access to hearing aids that heretofore required a prescription. The new rule, scheduled to take effect in mid ‐October, will benefit as many as30 million people who suffer from hearing loss.In 2017 Congress passed, and President Trump signed, theOver ‐the‐Counter Hearing Aid Act as a rider on the FDA Reauthorization Act of 2017. The Act created a new category of OTC hearing aids as devices using air conduction to improve hearing among adults with mi...
Source: Cato-at-liberty - August 16, 2022 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

Discussing the State of the TAME Clinical Trial, Metformin to Slow Aging
The TAME clinical trial, still not started, intends to assess the ability of metformin to marginally slow aging in humans. Back at the start of this initiative, it required a long process of negotiation on the part of the trial organizers with the FDA to produce an endpoint that was agreed upon to sufficiently represent aging. To my mind, the TAME trial initiative has already achieved what needs to be achieved: to get the FDA to agree that there is a way to run trials to treat aging. One doesn't actually need to run the trial, and there is in fact little point in running the trial. Metformin is almost certainly a marginal ...
Source: Fight Aging! - August 16, 2022 Category: Research Authors: Reason Tags: Daily News Source Type: blogs

Government Is the Scourge of Diabetics, Not Their Savior
Michael F. CannonCongressional Republicans have defeated a proposal by congressional Democrats to mandate that private insurance companies cap out ‐of‐pocket spending on insulin by their enrollees at $35 per month. Republicans were right to do so. Government is already driving insulin prices sky‐high. Further intervention would make matters worse.Diabetics need insulin to live. Insulin prices should be falling over time, yet they have more thandoubled over the last 10 years. Many diabeticsstruggle with those rising prices, sometimes withdeadly consequences. A humane health system would make in...
Source: Cato-at-liberty - August 8, 2022 Category: American Health Authors: Michael F. Cannon Source Type: blogs

FDA Moves to Expand NDC Numbering to Accommodate Rapid Rise in " Authorized Generic " Drugs
On July 22, 2022, the U.S. Food and Drug Administration ( " FDA " ) announced a proposed new rule (seehttps://www.federalregister.gov/documents/2022/07/25/2022-15414/revising-the-national-drug-code-format-and-drug-label-barcode-requirements for the announcement in theFederal Register, or the FDA ' s own page on the announcement athttps://www.fda.gov/drugs/drug-approvals-and-databases/proposed-rule-revising-national-drug-code-format, effectively Revising the National Drug Code Format and Drug Label Barcode Requirements (Docket No.FDA-2021-N-1351), that is intended to minimize the impact of the FDA running out of ten-digit n...
Source: Scott's Web Log - August 2, 2022 Category: Endocrinology Tags: authorized generic 2022 authorized generics FDA insulin NDC Source Type: blogs

Science Snippet: Lipids in the Limelight
This study could inform the advancement of new antibiotics.Developing new imaging technologies to track lipid droplet formation and breakdown in cancer cells. Understanding this phenomenon could shed light on why lipid droplets accumulate in these cells, which could aid in creating new therapies. Learn about other scientific terms with the NIGMS glossary. (Source: Biomedical Beat Blog - National Institute of General Medical Sciences)
Source: Biomedical Beat Blog - National Institute of General Medical Sciences - July 27, 2022 Category: Research Authors: Chrissa Chverchko Tags: Cells Chemistry, Biochemistry and Pharmacology Cellular Processes COVID-19 Medicines Science-snippet Source Type: blogs

Marketing Authorization at the FDA: Paradigms and Alternatives
Adam I. Muchmore (Penn State University), Marketing Authorization at the FDA: Paradigms and Alternatives, 74 Admin. L. Rev. (2022): In many critical industries, the Food and Drug Administration ’s (FDA’s) marketing authorization decisions determine the range of products available in the... (Source: HealthLawProf Blog)
Source: HealthLawProf Blog - July 13, 2022 Category: Medical Law Authors: Katharine Van Tassel Source Type: blogs

Novavax may be able to provide equitable access to another vaccine alternative
On June 7th, 2022, the Novavax COVID-19 vaccine was approved for use in adults by the Vaccine Advisory Committee of the United States Food and Drug Administration. The vaccine has already been authorized in many other nations, including Indonesia, the United Kingdom, Canada, Australia, and more, making the U.S. one of the last major nationsRead more …Novavax may be able to provide equitable access to another vaccine alternative originally appeared inKevinMD.com. (Source: Kevin, M.D. - Medical Weblog)
Source: Kevin, M.D. - Medical Weblog - July 7, 2022 Category: General Medicine Authors: < span itemprop="author" > < a href="https://www.kevinmd.com/post-author/vibhav-prabhakar-tejas-sekhar-and-divya-srinivasan" rel="tag" data-wpel-link="internal" > Vibhav Prabhakar, Tejas Sekhar, and Divya Srinivasan < /a > < /span > Tags: Meds COVID Source Type: blogs

FDA Wisely Permits Pharmacists to Prescribe Paxlovid
Jeffrey A. SingerWhen the Food and Drug Administration granted Emergency Use Authorization to the antiviral drugs Paxlovid and monupiravir in the beginning of this year, I co ‐authored anoped in the New York Daily News, along with Josh Bloom of the American Council on Science and Health, complaining about, among other things, the FDA ’s requirement that a patient who tests positive for COVID must get a prescription from a doctor, nurse practitioner, or physician assistant to obtain the drug. For the drugs to be effective they must be started within five days of the start of COVID symptoms. Not ev...
Source: Cato-at-liberty - July 7, 2022 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

Bonus Features – July 3, 3022 – Judge says Apple infringed AliveCor ’ s patent, more than half of patients have trouble managing their records, and more
This article will be a weekly roundup of interesting stories, product announcements, new hires, partnerships, research studies, awards, sales, and more. Because there’s so much happening out there in healthcare IT we aren’t able to cover in our full articles, we still want to make sure you’re informed of all the latest news, announcements, and stories happening to help you better do your job. News An International Trade Commission (ITC) judge has ruled that Apple infringed AliveCor’s patented personal electrocardiogram technology. The judge’s decision follows two complaints that AliveCor filed against App...
Source: EMR and HIPAA - July 3, 2022 Category: Information Technology Authors: Brian Eastwood Tags: C-Suite Leadership Health IT Company Healthcare IT Hospital - Health System AliveCor Andy Powell Apple Autonomous Revenue Cycle Management Cedar Gate Technologies DarioHealth DrFirst ECG Patents Harmony Health IT Healthcare IT To Source Type: blogs

Off-Label Speech
David A. Simon (Harvard Law School), Off-Label Speech, Emory L. J. (2022): This Article argues that the Food and Drug Administration ( “FDA”) should regulate drug manufacturer speech about off-label uses based on the evidentiary support for the relevant use. The... (Source: HealthLawProf Blog)
Source: HealthLawProf Blog - June 29, 2022 Category: Medical Law Authors: Katharine Van Tassel Source Type: blogs

Supreme Court Sets Higher Bar for Prosecuting Doctors Who Prescribe Opioids for Pain
Jeffrey A. SingerToday the U.S. Supreme Court unanimously overturned lower court decisions in the consolidated cases ofRuan vs. United States and Kahn vs. United States. The two physicians were convicted of prescribing opioid pain medicine “outside the usual course of [medical] treatment” and were sentenced to prison.The jury inRuan was not instructed to consider Dr. Xiulu Ruan ’s “good‐faith defense,” i.e., that he was indeed prescribing the drug “legitimately” to treat pain based upon his good‐faith assessments of his patients’ medical contexts and requirements. The Eleventh Circuit Appeals Cour...
Source: Cato-at-liberty - June 27, 2022 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs