FDA Law Blog

JULY 17, 2024

An Opportunity to Leverage the Newly Created Rare Disease Advisory Committee across CDER and CBER In Frank and James’ 2018 proposal there was also a recommendation for the formation of a Rare Disease Advisory Committee, which would allow FDA access to experts in the science of small trials and other aspects of rare disease research.

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FDA Law Blog

DECEMBER 2, 2024

We noted that the draft guidance’s discussion on determining a device’s contact duration raised concern as it contradicted ISO 10993-1:2018, Biological evaluation of medical devices —Part 1: Evaluation and testing within a risk management process. the new draft guidance and ISO 10993-1: 2018) leads to more uncertainty for sponsors.

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The Clinical Problem Solvers

OCTOBER 18, 2022

2018 Sep;142(3):e20174314. Epub 2018 Jul 9. Health Care Use and Health Behaviors Among Young Adults With History of Parental Incarceration. Pediatrics. doi: 10.1542/peds.2017-4314. Pediatrics. 2019 May;143(5): PMID: 29987170. Heard-Garris N, Johnson TJ, Hardeman R.

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FDA Law Blog

SEPTEMBER 26, 2022

FDA published a proposed list on June 13, 2018 (83 FR 27609), which we blogged about here. The list of alternative mechanisms for complying with Part 211 in this FR Notice is not different from what was proposed in the 2018 FR Notice. or that FDA proposes can satisfy the requirements in § 4.4 much like an FDA guidance document.

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PEMBlog

OCTOBER 18, 2024

Duchenne Muscular Dystrophy (DMD) is a complex and progressive disease requiring highly specialized care, especially in emergency situations. 2018 Oct;142(Suppl 2):S72-S81. 2018-0333I. The condition affects multiple organ systems—muscular, cardiac, and respiratory—leading to a myriad of clinical complications. Pediatrics.

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The Clinical Problem Solvers

DECEMBER 16, 2020

September 12, 2018. Use of Risk Assessment Tools to Guide Decision-Making in the Primary Prevention of Atherosclerotic Cardiovascular Disease: A Special Report From the American Heart Association and American College of Cardiology [published correction appears in J Am Coll Cardiol. Links References discussed throughout episode Tsai J.

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FDA Law Blog

OCTOBER 25, 2021

It was published approximately three years after the December 7, 2018 release of the proposed rule (see blog post on the proposed rule here ). The rule became final on October 5, 2021 via publication in the Federal Register. The new rule will be codified in 21 C.F.R. Part 860. Part 807, Subpart E) and the PMA regulations (21 C.F.R.

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PEMBlog

APRIL 20, 2023

A special thanks to Dr. Cristina Tarango, director of the Hemophilia Treatment Center at Cincinnati Children’s and Lisa Littner, Project Manager at Cincinnati Children’s who helped me research and write this post. …and it’s called Hemlibra (Emicizumab) Why this med is important and why kids are on it?

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FDA Law Blog

FEBRUARY 27, 2023

While no “special registration” will yet be required to engage in telemedicine prescribing of controlled substances, DEA is proposing parameters to guide the practice of telemedicine encounters in a post-COVID world. The Act also established new definitions for “Internet,” “online pharmacy,” “practice of telemedicine,” among others.

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FDA Law Blog

NOVEMBER 20, 2024

of ISO 10993-1:2018, but is extremely burdensome and not referenced in the related ISO 10993-18. It is recommended to submit a Pre-Submission to the Agency when considering your chemical characterization strategy, especially for any devices/materials with special considerations or use of alternative strategies and solvents.

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FDA Law Blog

JUNE 23, 2021

For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. Over the years, this function expanded to cancer (renamed the Office of AIDS and Special Health Issues) and, ultimately, all serious and life-threatening diseases (dropping the AIDS nomenclature). 7, 2017).

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FDA Law Blog

JULY 10, 2023

Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 Average Number of Industry Days to MDUFA IV Decision 54.69

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Annals of Family Medicine

NOVEMBER 20, 2024

Population Studied Inclusion criteria were ages 16-45 with a DME performed between 2018 and 2023. Results Among 118 newcomer women, 39 (33%) were pregnant 1-3 times from 2018-2023 with a total of 51 recorded pregnancies after US arrival.

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GeriPal

MAY 19, 2022

I think part of it’s the math, but I think what really happened is, I think the story here is that in 2018, MD Anderson published this really landmark study by Dr. Reddy and her colleagues about going from IV Dilaudid to other to oral Dilaudid, oral hydromorphone, I should say, oral morphine and oral oxycodone. I could put them on 7.5

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Physician's Weekly

JUNE 19, 2025

The Health Resources and Services Administration projects a 50% increase in demand for geriatricians from 2018 to 2030, when the entire baby boom generation will be older than 65. Their growth has bolstered primary care, and, like doctors, they can specialize in particular branches of medicine. ” In 27 states and Washington, D.C.,

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The Clinical Problem Solvers

FEBRUARY 8, 2023

There is a special emphasis on the use of public health models that prioritize harm reduction and person-centered care to prevent drug-related fatalities and curb the opioid epidemic along lines of race and class. 2018 Jun;46(2):404-421. Equity in Progress: Development of Health Equity Curricula in Three Psychiatry Residency Programs.

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GeriPal

SEPTEMBER 7, 2023

William: So ASCO decided to make a high priority this year to redo the guidelines, which were originally released in 2018. So I make the point, they often say, “Oh, you have this special population,” like pediatrics, where it’s 10% or something. Do you worry about that? We actually have the majority.

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GeriPal

OCTOBER 10, 2024

In 2018, survey data revealed that only 41% of survey adult practices had the full complement of funded core team members, which is up from 25% of 2016. There are very few palliative care fellowships for social workers, very few specialized programs who teach palliative care as a specialty area. The National Palliative Care Registry.

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GeriPal

JUNE 29, 2023

This week we’re going on to episode two, which is for me one of the most special episodes we’ve done in GeriPal for a very, very long time. Eric: And in the end, we have a very special part where we actually get a tour of their gardens outside of the hospice unit. Gerald: As soon as they opened this garden up in 2018.

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FDA Law Blog

JUNE 10, 2025

DEA publishes the Special Surveillance List to inform about potential illicit uses of a laboratory supply and reminds that civil penalties may be imposed on businesses that distribute a laboratory supply with reckless disregard for the illegal uses to which it will be put. DEA published the original Special Surveillance in May 1999.

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GeriPal

JULY 13, 2023

Summary Transcript Summary Today’s podcast is a follow up to our 2018 podcast with Randy Curtis about the Jumpstart intervention. It’s really special to be here and to be talking about this paper, which was really important to Randy. So what’s changed since 2018 with Jumpstart? Erin: Yeah, I can go first.

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Patient-Centered IT Patients Hospital 84

GeriPal

MARCH 27, 2025

And that included scheduling a visit with a, with a facilitator who had been specially trained. And as I mentioned, this study was proposed in 2018 before COVID The world is vastly different today than it was in 2018. Why did you even bother doing this study? Jennifer 04:34 Yeah, thanks for the question.

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Primary Care IT Clinic Patient-Centered 79

GeriPal

APRIL 21, 2022

So after my last chemotherapy in 2018, I came here to my healing place of Hawaii and spent time alone, and this poem, Hawaiian Waters, flat black lava, resting green sea turtles, gentle, translucent turquoise water and waves.

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FDA Law Blog

MAY 14, 2021

In 2009, Congress specifically exempted “tobacco or menthol” when it prohibited all other flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA)’s “ Special Rule for Cigarettes.” We also need input from the public.”. at § 387g(d)(2). How will the flavored cigar ban affect premium cigars?

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FDA Law Blog

MAY 14, 2021

In 2009, Congress specifically exempted “tobacco or menthol” when it prohibited all other flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA)’s “ Special Rule for Cigarettes.” We also need input from the public.”. at § 387g(d)(2). How will the flavored cigar ban affect premium cigars?

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Pamela Wible MD

JUNE 19, 2025

Isn’t it weird that now we’re labeling the majority of doctors with burnout in 2018? I assume most of you in here are not super specialized doing lung transplants and needing a helipad and tertiary-care hospital. Say I’m having a special. You don’t have to be special. Doesn’t make any sense.

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Physician's Weekly

JUNE 17, 2025

Since the drug trial started in 2018, some of her adult patients have begun living independently, getting into college, and starting jobs — milestones that once felt impossible. Dean attends a special education program, his mother said. She said the impact she’s seen is life-changing.

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FDA Law Blog

FEBRUARY 12, 2025

For some background (which is covered in more detail in one of our previous posts on the subject ), in 2009, Congress specifically exempted tobacco or menthol when it prohibited all other flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA)s Special Rule for Cigarettes.

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FDA Law Blog

JUNE 23, 2024

This information was widely publicized, and we are aware that industry practice evolved whereby pharmacies would deliver or dispense to practitioner’s office in certain cases including those discussed above. However, two events conspired to undermine this prior guidance.

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PEMBlog

MAY 9, 2024

2018 Nov;142(5):e20181009. Epub 2018 Oct 8. Morata and colleagues did a single center perspective randomized control trial back in 2018 that noted that regular antipyretics may reduce the recurrence of febrile seizures during the same fever episode, so during that illness. Pediatrics. doi: 10.1542/peds.2018-1009. PMID: 30297499.

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