FDA Law Blog

SEPTEMBER 26, 2022

provides an optional alternative streamlined approach for current good manufacturing practices (cGMPs) for manufacturers of drug-device combination products (CPs). FDA published a proposed list on June 13, 2018 (83 FR 27609), which we blogged about here. 21 C.F.R. § or that FDA proposes can satisfy the requirements in § 4.4

Manufacturing 40

Manufacturing Specialization Provider Medical 40

PEMBlog

OCTOBER 18, 2024

Duchenne Muscular Dystrophy (DMD) is a complex and progressive disease requiring highly specialized care, especially in emergency situations. Emergency Care Plans and Advanced Directives Many DMD patients will arrive with comprehensive emergency care plans or letters from their providers. 2018 Oct;142(Suppl 2):S72-S81.

Patients 52

Patients Complication Management Consulting 52

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. a)(3), provided certain requirements, including requirements under state laws and conditions are met. 21 U.S.C. §

Telemedicine 59

Telemedicine Telecommunication Telehealth Medical 59

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 ). As to the testing facility inspections, without more explanation than was provided in the preamble, it is not clear how section 513(a)(1)(C) provides authority. Part 860.

Manufacturing 52

Manufacturing Government Specialization IT 52

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. By Day 100 If MDUFA Decision is not reached by Day 100, FDA provides Missed MDUFA Decision Communication that identifies outstanding review issues. 510(k) Time to MDUFA IV Decision.

Provider 75

Provider IT Engineering Medical 75

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.

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

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?

Individual 52

Individual Patient-Centered Patients IT 52

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).

Patients 52

Patients Patient-Centered Clinic IT 52

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. “We step into places where other providers may not, and geriatrics is a prime example of that.” ” In 27 states and Washington, D.C.,

Nurse Practitioner 52

Nurse Practitioner Family Families Primary Care 52

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. They can use their training and privilege to advocate for meaningful policy reform.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

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.

Patient-Centered 129

Patient-Centered IT Patients Clinic 129

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.

Specialization 69

Specialization Manufacturing Electronics PCP 69

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.

Patient-Centered 84

Patient-Centered IT Patients Hospital 84

GeriPal

MARCH 27, 2025

And so a lot of it was the facilitators calling out with the approval of the provider to the patients ahead of time to see, like, you have a visit coming up. And that included scheduling a visit with a, with a facilitator who had been specially trained. Why did you even bother doing this study? It’s a great question.

Primary Care 79

Primary Care IT Clinic Patient-Centered 79

GeriPal

APRIL 21, 2022

To the deeper emotions – of loss and grief, of wonder and transcendence – that are at the heart of the complex care we provide. Like Alex said, it’s not just about the nortriptyline and the new opioid receptors, that there’s something else that makes the work we do special. AlexSmithMD .

Patient-Centered 93

Patient-Centered IT Community Illness 93

Pamela Wible MD

JUNE 19, 2025

Isn’t it weird that now we’re labeling the majority of doctors with burnout in 2018? I’m just actually providing really good primary health care. 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.

Clinic 246

Clinic Nurse Practitioner IT Medical 246

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.

Patient-Centered 52

Patient-Centered Emergency Room Insurance Patients 52

FDA Law Blog

JUNE 23, 2024

For example, intrathecal infusion therapy, via an implanted infusion pump, or Targeted Drug Delivery (TDD”), is a last-line therapy for patients who have failed all other conventional pain therapies. However, two events conspired to undermine this prior guidance.

IT 98

IT Medical Patients Specialization 98

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.

Illness 59

Illness Vaccination Family Families 59