FDA Law Blog

JULY 6, 2023

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this year, neither the Quality System Regulation (QSR) nor the Quality Management System Regulation (QMSR) were referenced in the semiannual regulatory agenda. According to the Unified Agenda, the proposed rule is in the final rule stage.

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FDA Law Blog

OCTOBER 27, 2022

The updated final guidance now also incorporates ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product lifecycle Management. The final guidance includes several changes that are summarized below. FDA added examples in Section V of the guidance of modifications to an approved CP that must be submitted as an annual report.

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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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The Clinical Problem Solvers

DECEMBER 16, 2020

Tsai has seen race-based medicine play out in clinical practice 10:45 What role should race play in making clinical decisions? 13:16 Status of the current conversation on removing race from eGFR calculators: why is it so contentious? Poet Marge Piercy has written, “The work of the world is as common as mud.”

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FDA Law Blog

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The final rule emphasizes risk management activities and risk-based decision making. The new § 820.10

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FDA Law Blog

MARCH 6, 2022

Part 820, with a newly named Quality Management System Regulation (QMSR). The QMSR omits many of the specific QSR requirements that currently appear in the regulations, and instead incorporates by reference an international standard for medical device quality management systems.

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FDA Law Blog

APRIL 11, 2022

Shapiro — One of the more complex areas of device regulation is the management of risks associated with malfunctions reported from the field. A critical task in this situation is for a firm to estimate the risk posed by the issue as accurately as possible. A December 2021 warning letter to Medtronic, Inc. Is FDA’s criticism valid?

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FDA Law Blog

FEBRUARY 22, 2023

By Jeffrey K. Shapiro — More than a decade ago, FDA began systematically to incorporate review of human factors (HF) design validation within 510(k) reviews. Industry would certainly welcome guidance intended to smooth the HF aspects of 510(k) reviews. But there is a very big fly in this ointment. This approach is one-size-fits-all.

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FDA Law Blog

MAY 31, 2021

In addition, CMS proposes to extend the effective date of a 2016 regulation that requires AMP and Best Price to include sales to purchasers in the U.S. This forces patients ultimately to pay the amounts subsidized by a manufacturer in order to meet their deductibles or maximums. CMS Proposes to Extend Effective Dates of Two MDRP Regulations.

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FDA Law Blog

APRIL 20, 2021

Remove non-device software functions intended for storing and displaying medical images, clarify that the regulation includes software and hardware functions intended for medical image management and processing, and revise the title of the classification regulation to “Medical Image Management and Processing System”. By McKenzie E.

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FDA Law Blog

NOVEMBER 20, 2024

Since the first issuance of FDA’s guidance Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” in 2016, sponsors submitting premarket submissions to FDA have had the option of using these techniques to evaluate certain biocompatibility endpoints.

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PEMBlog

SEPTEMBER 24, 2024

Management of Congenital Lung Malformations. doi: 10.1128/microbiolspec.TNMI7-0032-2016. The CT also showed normal pulmonary venous return via the left lower pulmonary vein. Additionally, the CT revealed findings most consistent with necrotizing pneumonia within the sequestered portion of the lung and a small left pleural effusion.

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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. While the final guidance continues to borrow some IMDRF concepts, it no longer limits Non-Device CDS to software that informs clinical management (per the IMDRF guidelines).

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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. 7,838 (Feb.

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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

OCTOBER 10, 2024

Show me your scars.” Scars, really? I’ve been there. You probably have too. On the one hand, I don’t think interprofessional teamwork needs to be scarring. On the other hand, though it goes against my middle-child “can’t we all get along” nature, disagreement is a key aspect of high functioning teams. Alex 02:38 Love it.

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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 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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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 14, 2022

Management of chronic pain in the elderly: focus on transdermal buprenorphine. 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. Transcript. This is Eric Widera.

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Physician's Weekly

JUNE 11, 2025

Despite the emphasis on U=U as a key HIV prevention strategy since 2016, none of the included studies explicitly described U=U or U=U messaging as an intervention component,” the researchers wrote. The systematic review of peer-reviewed intervention was published from 2018 to 2023. Of the 669 participants, the mean age from studies was 45.4

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GeriPal

APRIL 3, 2025

We used all of our political capital to make sure it happens in Chicago, which is where we started for the literature Updates back in 2016, back when it was just me and Ken, and then we brought in Alex, like two years later. Annie 05:16 So if you look back in history, I think Eric and Ken have been doing this since 2016. Of course.

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FDA Law Blog

FEBRUARY 9, 2022

10, 2016); East Main Street Pharmacy; Affirmance of Suspension Order, 75 Fed. 10, 2016); East Main Street Pharmacy; Affirmance of Suspension Order, 75 Fed. DEA investigated Gulf Med because it was one of the top ten purchasers of oxycodone, hydromorphone and hydrocodone in Florida. Holiday CVS, 77 Fed. and SND Health Care, L.L.C.;

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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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Permanente Medicine

APRIL 29, 2025

From 2012 to 2016, death rates from colorectal cancer among Black people were nearly 40% higher than in whites and double that seen in Asians and Pacific Islanders, according to the American Cancer Society. Deaths per 100,000 for Hispanic, white, and Asian patients decreased to 20 during the same time period.

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FDA Law Blog

MAY 5, 2024

The White House Office of Management and Budget will review the rescheduling proposal. FDA/HHS Analysis, 2023 FDA/HHS last conducted an eight-factor analysis of marijuana in 2016 and concluded that marijuana continued to meet schedule I criteria. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed.

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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

JULY 28, 2022

But at that time I was struck by how in that field, there wasn’t a focus or really interest in symptom management and support for patients and their families. 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. .

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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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The Clinical Problem Solvers

MAY 30, 2022

Kozhimannil—the Distinguished McKnight University Professor in the Division of Health Policy and Management at the University of Minnesota and Director of the Rural Health Research Center. Published April 20, 2016. and a professor.” This policy reflects a societal belief that humans are not valuable unless they provide a service.

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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. You get me with one-finger-chords on the guitar if you’re watching on YouTube (best I could manage). Four percent. It is the slippery slope made real.

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GeriPal

JUNE 30, 2022

Should she be treated non-operatively, with aggressive symptom management? Should she have an operation, and risk the pain, potential complications, and attendant delirium associated with the operation? Eric: So we’re going to be talking about dementia and considerations around surgery for individuals with dementia. It was Remember Me.

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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

FEBRUARY 5, 2024

When finalized, the Draft Guidance will take the place of the 2016 guidance Collection of Race and Ethnicity Data in Clinical Trials. Instead, the information should be self-reported or, if that is not possible, provided by a first-degree relative or knowledgeable representative. The comment period ends on April 29, 2024.

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PEMBlog

DECEMBER 14, 2023

Learn all about diagnosis and management of this common problem in this brief podcast episode. 2016 Apr;83:78-83. Laryngomalacia, is the most common cause of infant stridor. Early diagnosis is crucial as it can impact a child’s growth and development. 2005 Nov;128(5):3391-7. Isaac A, Zhang H, Soon SR, Campbell S, El-Hakim H.

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PEMBlog

MARCH 27, 2024

This episode will help you better prepare for and manage children with inborn errors of metabolism in the Emergency Department. 2016 Jan;37(1):3-15; quiz 16-7, 47. As always, I’m your host, Brad Sobolewski, and this episode focuses on the management of children with metabolic disorders who present to the emergency department.

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FDA Law Blog

JUNE 19, 2023

In the most recent Unified Agenda, which is a list of planned regulatory actions published semi-annually by the Office of Management and Budget (OMB), FDA announced its intent to issue a proposed rule “to make explicit that laboratory developed tests (LDTs) are devices under the Federal Food, Drug, and Cosmetic Act.”

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