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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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. marijuana manufacturers, importers, exporters, and distributors will be required to obtain DEA registrations, and prescriptions will be required for dispensing marijuana to individuals.

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FDA Law Blog

OCTOBER 5, 2022

The proposed rule is intended to align with current nutrition science, the Dietary Guidelines for Americans 2020-2025 and the 2016 nutrition labeling regulation (which also was intended to align with the Dietary Guidelines for Americans). The healthy claim has been the topic of much discussion and challenged in consumer class actions.

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The Clinical Problem Solvers

DECEMBER 16, 2020

Moreover, center patients not only in discussions about individual decision-making but in constructing and drawing meaning from the research. Tsai has seen race-based medicine play out in clinical practice 10:45 What role should race play in making clinical decisions?

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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.) In defending the complete broadcast, Lilly called out similar elements from each of the individual components as demonstrating its intent to have all three viewed sequentially.

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FDA Law Blog

SEPTEMBER 6, 2022

This Draft Guidance, when finalized, will replace the Final Guidance issued just six years ago (the 2016 Guidance). Changes from the 2016 Guidance. Livornese — FDA recently published a Draft Guidance entitled “Charging for Investigational Drugs under an Investigational New Drug Application: Questions and Answers” (the Draft Guidance).

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FDA Law Blog

NOVEMBER 1, 2023

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software. Premarket Approval or De Novo pathways). This comparison is misplaced.

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FDA Law Blog

FEBRUARY 21, 2024

Subpart A – General Provisions Subpart A – General Provisions, incorporates by reference ISO 13485:2016 and Clause 3 of ISO 9000:2015 (new § 820.7), and requirements for a quality management system (new § 820.10). The final rule emphasizes risk management activities and risk-based decision making. The new § 820.10

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FDA Law Blog

JUNE 29, 2022

Livornese — Last week, FDA issued a draft guidance entitled “Considerations for Rescinding Breakthrough Therapy Designation” (the Draft Guidance ), authored by CDER, CBER, and the Oncology Center of Excellence (it is interesting, though not surprising, to see the OCE as an author on this document, given the popularity of the program in oncology).

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FDA Law Blog

JUNE 23, 2021

For example, we know that cancer patients have a high tolerance for toxicity when offered a chance at improved survival, a risk tolerance that would not be shared by individuals suffering from the common cold. the morbidity, oftentimes irreversible and progressive, and morality associated with their condition).

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FDA Law Blog

OCTOBER 10, 2022

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. Specifically, the guidance interprets the Cures Act’s four criteria for exclusion of CDS software functions from FDA’s medical device jurisdiction (so-called “Non-Device CDS”).

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FDA Law Blog

APRIL 13, 2021

The monologue above raises a few key points that we will address individually. This was the strategy employed when the emergency was declared for the Zika virus back in August 2016. We’re now making nine decisions a day. Not all decisions are authorizations. How many of the decisions are Authorizations?

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FDA Law Blog

MARCH 17, 2022

We blogged on the final 2016 guideline here on March 17, 2016). As explained more fully below, CDC concedes that states, insurers, pharmacies and pharmacy benefit managers have implemented laws, regulations and policies that have misapplied the 2016 guideline. 2016 Guideline. Purpose of the Proposed Guideline.

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The Motivated MD

SEPTEMBER 19, 2024

For the better half of 2024, I have been periodically writing posts that are individual articles that double as potential chapters to a future book. Before we discuss each individual savings account, let us first highlight exactly what it means to ‘automate’ your savings. So yes, humans make mistakes.

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GeriPal

DECEMBER 15, 2022

Summary Transcript Summary. We’ve talked at length on prior podcasts about the failures of aducnumab, Biogen, and the FDA’s decision to approve it. . But wait, there’s a shiny new anti-amyloid drug, lecanemab! (No No it’s not just the French version of Aducanumab). . In an article in the NEJM (a published article this time, wonder of wonders!)

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GeriPal

FEBRUARY 15, 2024

Going into patient’s homes was eye opening. There were trip hazards, loose carpets, some people were hoarders. And yet, after assisting the older adult to their feet, the EMS providers would leave. Their job was done. It’s not surprising that the number of repeat calls for falls is alarmingly high. Alex: I think this is a first.

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The Clinical Problem Solvers

DECEMBER 20, 2021

Fields Guests: Thu Quach, PhD, and Tung Nguyen, MD Time Stamps 00:00 Introduction 04:00 How Dr. Thu Quach’s and Dr. Tung Nguyen’s journeys shape their work 11:40 Policy work as a way of mitigating burnout 12:55 Balancing individual and communal focus (include?) Remember that more deeply understanding your patients can provide meaning!

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FDA Law Blog

NOVEMBER 29, 2022

Houck — On November 4th, CDC issued its revised guideline on prescribing opioids for pain as an expansion and update of its 2016 CDC Opioid Prescribing Guideline. We blogged on the 2016 guideline here in March 2016, and the proposed guideline here on March 18th). By Larry K. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R.,

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GeriPal

FEBRUARY 29, 2024

The hot sauces progressed from mild to extreme (and I mean extreme) heat. Can I just say…it works? Being asked a question with your mouth on fire, sweat streaming down your face, feeling the most awake and terrified you have ever been in your life, forces you to give an unadorned answer, straight from the heart. Lynn: Okay. Anne: GeriPal edition.

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GeriPal

APRIL 3, 2025

Annie 02:31 So if you go to the A G S meeting every year, you know that this group of three individuals comprises the AGS literature update. Annie 05:16 So if you look back in history, I think Eric and Ken have been doing this since 2016. Eric 02:26 We found him in the hallway back there [laughter]. So this is something. Of course.

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FDA Law Blog

FEBRUARY 9, 2022

DEA regulations state that a pharmacist has a corresponding responsibility not to fill a prescription unless it is issued for a “legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” 10, 2016); East Main Street Pharmacy; Affirmance of Suspension Order, 75 Fed.

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FDA Law Blog

DECEMBER 18, 2022

Generally, FDA’s MDR regulations require device manufacturers to submit Medical Device Reports (MDRs) for individual reportable malfunctions within 30 calendar days of the manufacturer becoming aware of the malfunction. The VMSR Program allows manufacturers to bundle malfunction reports of “like events” together in a single summary report.

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GeriPal

DECEMBER 8, 2022

Summary Transcript Summary. Eric and I weren’t sure what to call this podcast – storytelling and medicine? Narrative medicine? We discussed it with today’s guests Heather Coats, palliative care NP-scientist, and Thor Ringler, poet. It wasn’t until the end that the best term emerged – storycatching. It’s since spread to over 70 VAs.

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GeriPal

APRIL 14, 2022

So I have thought about this for months, maybe years since your 2016, cycle blog, but we have picked Under Pressure by David Bowie and Queen. It’s been around for a long time but is acting like the hot new kid in town. But does this drug really live up to the hype? Eric: And why Under Pressure. So here we go. A little bit of under pressure.

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GeriPal

MARCH 28, 2024

I’m just stunned even writing that! We’ve come so far as a field. This isn’t to say we’ve “made it” – more to say that we’ve reached a new stage of maturation of the field – in which the evidence we are discussing is frequently high quality randomized trial level data. -@AlexSmithMD Transcript Eric: Welcome to the GeriPal podcast.

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FDA Law Blog

MAY 5, 2024

Houck — The Associated Press reported on Tuesday following confirmation by five anonymous individuals with knowledge that the Drug Enforcement Administration (“DEA”) is moving to reschedule marijuana from schedule I to the less stringently controlled schedule III. By Larry K. 29, 2023). Letter to U.S. 21 U.S.C. § 812(b)(1). 53,688 (Aug.

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GeriPal

JUNE 30, 2022

Eric: So we’re going to be talking about dementia and considerations around surgery for individuals with dementia. Samir: Thanks, Alex and Eric. Before we go into this topic, who has a song request for Alex? It was Remember Me. Was that the title? Alex: I think it’s I Will Remember You. Alex: By … Joel: Sarah McLachlan.

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Patient-Centered Complication Patients IT 101

GeriPal

JANUARY 11, 2024

The number of people who have used MAID in Canada since it was legalized in 2016 has increased year on year from about 1,000 people in the first year to over 13,000 people in 2022. Summary Transcript Summary Four percent of deaths in Canada are due to Medical Assistance in Dying (MAID). Four percent. It is the slippery slope made real.

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The Clinical Problem Solvers

MAY 30, 2022

She urges us to recognize that maternal mortality changes the life trajectories of individuals and communities. Published April 20, 2016. These statistics not only reflect the number of birthing people dying in childbirth but also evince the number of children growing up without a parent and the number of families losing a loved one.

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GeriPal

APRIL 10, 2025

I think back in what, May 2016, you published a randomized controlled trial, first author, palliative care and the ED randomized study, cancer patients. Eric 04:26 So that 2016 study was in the ED, but it was getting specialty palliative care to see them when they were hospitalized, is that right? They got feedback. So did it matter?

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GeriPal

OCTOBER 5, 2023

Summary Transcript Summary Communicating about a serious illness is hard. Last week’s podcast we talked about the challenge around miscommunication in serious illness. This week we dive into the challenges with communication when it comes to life sustaining treatments and CPR. Welcome to the GeriPal podcast. Jacky: Thank you. It’s a pleasure.

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BMJ

FEBRUARY 8, 2021

Besides the risks to an individual, there are also population-level harms from normalizing certain harmful behaviors (e.g., Tobacco and Marijuana Use Among US College and Noncollege Young Adults, 2002-2016. 2 Opioids contribute a large share of this overdose crisis. 3 To respond to this crisis, the U.S. Pediatrics. doi: 10.1542/peds.2019-1372.

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PEMBlog

MARCH 27, 2024

She aims to become a physician-scientist in pediatrics and medical genetics, engaging in bench-to-bedside research that utilizes multi-omics-based approaches to provide a molecular diagnosis and support personalized care for individuals with suspected rare genetic diseases and their families. 2016 Jan;37(1):3-15; quiz 16-7, 47.

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GeriPal

JULY 28, 2022

Jennifer’s study is most widely known for the “kicker” – not only did it improve quality of life, palliative care was associated with a couple months longer survival. . Areej’s study is remarkably novel in that it is, to our knowledge, the first study of palliative care during curative treatment. . Alex: (singing). Areej: Wow.

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GeriPal

AUGUST 25, 2022

Eric: We have a smorgasbord, if you will, of papers that got published recently around hospice, and that’s why we’re calling it a hospice super special. We’re going to be talking about each one of these papers. But before we do, I think somebody has a song request. Is it you, Melissa? Melissa: It’s me. Yes, it is. Here we go.

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FDA Law Blog

JUNE 24, 2021

In 2016, FDA opened a docket seeking comments on “service, maintenance, refurbishment, and alteration of medical devices” by third parties (see our blog post here ). The draft guidance distinguishes between “remanufacturing” and “servicing” of devices.

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GeriPal

AUGUST 24, 2023

Just an extraordinary cast of individuals who were really so incredibly inspiring. Summary Transcript Summary I hear the word dignity used a lot in the medical setting, but I’m never sure what people mean when they use it. We talk with Harvey about how he defines “dignity” and how we can understand what it means to our patients.

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