The Medical Futurist

JUNE 21, 2025

In 2016, The Guardian reported that a blind woman suffering from this disease was fitted with the implant labelled “bionic eye” in the UK as part of a trial at the Oxford Eye Hospital. How far can you see and hear? When it comes to vision, it’s around 50 miles, talking about hearing, it’s only 1-2 miles at best! How about touching or tasting?

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Diabetes Patient-Centered IT Patients 98

Medical Xpress

FEBRUARY 24, 2023

Between 2016 and 2018, more than 22 percent of Massachusetts residents reported any prior cannabis use for medical or recreational reasons. As legislation in multiple states eases former restrictions around medical and recreational cannabis in the United States, an increasing proportion of the population reports use of the drug.

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Healthcare Patients IT Medical 98

Physician's Weekly

JUNE 18, 2025

It took artificial dyes out of Kraft Mac & Cheese in 2016, The WSJ said. WEDNESDAY, June 18, 2025 (HealthDay News) — One of the nation’s largest food companies is planning a big change to its ingredients list. Kraft Heinz said it will stop using artificial dyes in all U.S. products by the end of 2027. More information The U.S.

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Physician's Weekly

JUNE 24, 2025

Dr Vinson: I introduced the phrase in a 2020 essay I published after our initial 2016 case report. Vinson, MD , Kaiser Permanente Adjunct Investigator, Emergency Physician, and Research Chair, discussed his research team’s findings with Physician’s Weekly ( PW). PW: Who coined the term “cold drink heart”? Our study was relatively small.

Physicals 72

Physicals Primary Care Patients IT 72

Annals of Family Medicine

NOVEMBER 20, 2024

Setting or Dataset: A dataset was used, consisting of 350 long-term female breast cancer survivors included between 2013 and 2016 in general practices in the Netherlands. This ideally should be detected in primary care, since most specialist follow-up care for breast cancer is discontinued after five years. and a specificity of 66.6%

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The Medical Futurist

MAY 18, 2025

We have seen a number of examples, Canada experimenting with robot-comrades since the 2016 introduction of Ludwig , and some elderly care facilities in Ireland introducing Stevie to their residents. These new ‘colleagues’ will definitely make a difference in every field of medicine. But there is undoubtedly impressive progress.

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Physician's Weekly

JUNE 24, 2025

We need to ensure efficient throughput to allow us to provide access to as many patients as we can,” said David Schnadower, MD, MPH, of Cincinnati Children’s Hospital Medical Center in a news release. “An

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Medical Xpress

APRIL 18, 2023

According to a study published in 2017, 12% of the world's adult population was affected by obesity in 2016, double the percentage from 30 years earlier. Obesity and its associated cardiometabolic issues are a major health concern in the U.S. and internationally.

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Hypertension IT 75

FDA Law Blog

FEBRUARY 26, 2024

Koblitz & Kurt R. Karst — While the Biologics Price Competition and Innovation Act (“BPCIA”) is inherently distinct from the Hatch-Waxman Act, many of the fundamental concepts FDA adopted as it enacted the Hatch-Waxman Act made their way into FDA’s implementation of the BPCIA. FDA borrowed this definition from 21 C.F.R.

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Physician's Weekly

JUNE 24, 2025

So, in 2016, she celebrated her 60th birthday at her local CVS. Kim Beckham, an insurance agent in Victoria, Texas, had seen friends suffer so badly from shingles that she wanted to receive the first approved shingles vaccine as soon as it became available, even if she had to pay for it out-of-pocket.

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Vaccination Illness Hospital Patient-Centered 52

PEMBlog

JUNE 27, 2023

Bronstein, MD, 2016. It is summertime, so the bees and bugs are out! In this episode, Dr. Ben Grebber, a pediatric resident at Boston Children’s Hospital/Tufts Children’s Hospital, discusses Bee Stings and Spider Bites. Pansare, M., Kamat, A., & Kamat, D. Summer buzz: All you need to know about insect sting allergies.

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Primary Care Hospital IT 98

FDA Law Blog

APRIL 6, 2025

This opinion, which overrules a Fifth Circuit decision that FDA had acted arbitrarily and capriciously in denying premarket tobacco product applications submitted by manufacturers of flavored e-liquids for open-system e-cigarettes, marks the latest development in the ongoing debate and FDA regulation of flavored vape products.

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IT Manufacturing Provider Families 59

Plum Health

MAY 11, 2023

Thomas graduated from Wayne State University School of Medicine in 2013 - thereafter, he completed his residence at Oakwood/Beaumont Family Medicine Residency Program, and then started Plum Health DPC in November 2016. Time flies when you’re practicing medicine - the days are long but the years are short.

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Family Medicine DO Community Education 52

FDA Law Blog

OCTOBER 9, 2022

In 2016, DEA denied two petitions — originally filed in 2011 and 2009 — after HHS concluded that marijuana continued to meet schedule I criteria by having a high potential for abuse, no accepted medical use in the United States, and lacking an acceptable level of safety for use even under medical supervision.

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FDA Law Blog

JANUARY 18, 2023

Recall that CMS is required to negotiate and publish the 2016 maximum fair price for 10 high expenditure, single source Part D drugs by September 1, 2024. The memorandum also introduced the Program’s spanking new logo. The memorandum outlines CMS’s priorities and timeline for the Initial Price Applicability Year 2026.

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Manufacturing IT Provider Government 59

FDA Law Blog

DECEMBER 1, 2024

In September 2016, Nippon Fine Chemical received a similar Warning Letter about an attempt to prevent an FDA Investigator from taking photographs. In September 2016, Nippon Fine Chemical received a similar Warning Letter about an attempt to prevent an FDA Investigator from taking photographs.

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California Academy of Family Physicians (CAFP)

MAY 14, 2025

Proposition 56 Reductions California Proposition 56, also known as the California Healthcare, Research and Prevention Tobacco Tax Act of 2016, was a ballot initiative passed by voters in November 2016 to increase the tobacco tax.

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FDA Law Blog

JANUARY 30, 2025

Since its enactment, Congress has strengthened FOIAs disclosure provisions, most recently in 2016. Since its enactment, Congress has strengthened FOIAs disclosure provisions, most recently in 2016. These statutory changes combined with the foreseeable harm standard in the FOIA exemptions, gave the statute some additional teeth.

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Government Electronics Provider IT 66

FDA Law Blog

NOVEMBER 27, 2023

At the time, in 2016, the Gree Companies’ settlement for $15.45 17, 2023, the Department of Justice (DOJ) announced the first-ever conviction of two corporate executives in a criminal prosecution for failure to report a consumer product defect under the CPSA. What led to this conviction? It involved Gree Electric Appliances Inc.

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FDA Law Blog

OCTOBER 27, 2022

This final guidance provides recommendations to original applicants and holders of approved applications for human drugs and certain biological products on implementing chemistry, manufacturing, and controls (CMC) postapproval changes(s) through the use of a Comparability Protocol (CP).

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Manufacturing Provider Management IT 105

FDA Law Blog

JULY 31, 2023

Houck — President Barack Obama signed the Comprehensive Addiction and Recovery Act of 2016 (“CARA”) intended to reverse serious prescription drug abuse trend in the United States on July 22, 2016. By Larry K. Letter from Congress of the United States, to Robert Patterson, Acting Administrator, DEA (Dec. 78,282 (Dec.

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Electronics Consulting Patients Medical 98

FDA Law Blog

JANUARY 15, 2024

In 2016, FDA determined that e-cigarettes and their component parts fell under the term “new tobacco products,” requiring manufacturers of such products to submit PMTAs for FDA review before the Agency would issue a marketing order permitting the legal sale of the product.

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NPR Health

DECEMBER 20, 2024

She's been on dialysis for four hours a day, three days a week since 2016. Towana is a 53-year-old grandmother from Gadsden, Ala. Her immune system would reject a human kidney. So the Food and Drug Administration made an exception to its usual clinical study requirements to allow Looney this new kind of pig kidney.

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Clinic IT 55

FDA Law Blog

OCTOBER 13, 2024

Although the program has not been without its critics (including as documented in two GAO reports from 2016 and 2020 ), there is ample evidence that the program has been successful at accomplishing its goals, which has become more evident with time. Notably, it was reauthorized in 2016 (until 2020) and in 2020 (until 2024).

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Government IT Education Individual 64

FDA Law Blog

APRIL 25, 2023

Note that section 3060(a) of the 21st Century Cures Act in 2016 amended section 520 of the FD&C Act and removed certain software functions from the statutory definition of a medical device. A recent amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) added a new section about cybersecurity for “cyber devices.”

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FDA Law Blog

NOVEMBER 4, 2024

At that time, CVM informed Phibro that the company needed to submit data demonstrating that the product posed no health risk and, in 2016, issued a Notice of Opportunity for a Hearing proposing to withdraw approval for all carbadox NADAs. Phibro filed the instant lawsuit.

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IT Provider 64

FDA Law Blog

AUGUST 8, 2024

In the most recent eight factor analyses prior to August 2023, in 2016 HHS and DEA concluded that marijuana continued to meet criteria for remaining in schedule I. 12, 2016); Denial of Petition To Initiate Proceedings to Reschedule Marijuana, 81 Fed. Denial of Petition To Initiate Proceedings to Reschedule Marijuana, 81 Fed.

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Government Medical IT Manufacturing 59

FDA Law Blog

JANUARY 18, 2024

In 2016, FDA again threatened to remove it , but ultimately took no action for reasons that remain unclear. Last November, FDA published a notice of a proposal to withdraw approval of the three carbadox New Animal Drug Applications (“NADAs”) under 21 U.S.C. 360b(d)(1)(I). But did FDA pig out? In its whopping 70-page complaint.

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IT 59

FDA Law Blog

FEBRUARY 7, 2022

Back in 2016 and 2019 we reported on FDA’s objections to TV commercials that included fast-paced “compelling and attention grabbing visuals” (note the similar language) as they were competing for the consumer’s attention while the major statement conveyed risk information. So what’s the takeaway here?

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FDA Law Blog

APRIL 22, 2024

When DEA denied marijuana rescheduling petitions in August 2016, cannabis was listed as a schedule I and schedule IV substance under the Single Convention. . § 811(d) required classification of marijuana as a schedule I or II substance to comply with U.S. 811(d) and U.S. treaty obligations, and, if not, why has DEA’s position changed?

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FDA Law Blog

JANUARY 18, 2022

In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). This guidance document is still in effect today.

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Louisville Lectures

MAY 4, 2018

Disclaimers ©2016 LouisvilleLectures.org Happy Derby Day! It's the 144th Kentucky Derby and Louisville Lectures is ready to welcome summer with a small update regarding this blog series and website. Every summer we take a short break to ensure our content stays consistent as well as unique and without repeats.

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IT 52

FDA Law Blog

JUNE 14, 2022

Even a month of market exclusivity is financially lucrative enough to fight for, so it is no surprise that a company would go to the mat for an extra 13 months of patent exclusivity. Plain language, FDA explained, “evinces clear intent that it applies only to drugs scheduled after enactment.”

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FDA Law Blog

JUNE 3, 2025

However, the 2022 Clinical Practice Guideline, which updated the CDCs 2016 Guideline, notes that its recommendations are voluntary and intended to be flexible to support, not supplant, individualized, patient-centered care. Attorneys Office, Northern District of Illinois, April 21, 2025, quoted here. Recommendation 1. at Background.

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Clinical Practice Patient-Centered Patients Clinic 59

FDA Law Blog

APRIL 2, 2025

In that pre- Loper Bright case, FDA successfully defended its 2016 GRAS final rule. A few weeks ago, HHS released a press release stating that FDA had been directed to explore potential rulemaking to revise its Substances Generally Recognized as Safe (GRAS) Final Rule and related guidance to eliminate the self-affirmed GRAS pathway.

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Manufacturing Government IT 59

PEMBlog

OCTOBER 17, 2023

Clinical Pediatric Dermatology 5 th ed, Elsevier, 2016, 382-401. This is a viral exanthem caused by Parvovirus B19. It is rare and usually seen in young adults rather than children. It presents with acute onset, rapidly progressive, symmetric swelling and erythema of the hands and feet, often with petechiae or purpura. Gu SL, Jorizzo JL.

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Diagnose Diagnosis Clinic Patients 69

FDA Law Blog

JANUARY 26, 2022

Note that Allysa Seely is a Paralympian gold medal triathlete, and swimmer Ryan Murphy is a 2016 Olympian and gold medalist.) By Dara Katcher Levy — We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming!

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