The Clinical Problem Solvers

OCTOBER 18, 2022

All healthcare professionals will have patients who are directly or indirectly impacted by the carceral system. Additionally, our guests urge us to recognize the ways in which our patients are impacted by incarceration and to ask our patients about these impacts in order to better care for them.

Healthcare Professional 52

Healthcare Professional Healthcare Patient-Centered Mental Health 52

My Green Doctor

APRIL 4, 2025

In This Issue : New Research: Teaching Patients about Climate Resilience Make the Pledge Today to Go Green Get Ready for Earth Day 2025 (part 2)! from 2000 to 2018 among people over 65 years old. Patients rely on medical professionals for guidance on how lifestyle choices impact long-term health. Contact us today! of total U.S.

Healthcare Professional 52

Healthcare Professional Healthcare Community Medical Advice 52

PEMBlog

OCTOBER 31, 2024

Why is this important for patients and caregivers ? Caution While this study provides important insights, it is worth noting that probiotics may still play a role in other health contexts. However, for pediatric gastroenteritis, the evidence suggests they do not provide significant benefits. 2018 Nov 22;379(21):2002-2014.

Hospital 105

Hospital Illness Patients Provider 105

FDA Law

MAY 13, 2024

FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices. In fact, in 2018, FDA emphasized that leveraging the use of RWD and RWE in regulatory decision-making is “a top strategic priority for the FDA.”

Medical 111

Medical Clinic Patients IT 111

FDA Law

JULY 17, 2024

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. By Sarah Wicks & James E. Valentine & Frank J.

Patient-Centered 105

Patient-Centered Community Medical Specialty Clinic 105

FDA Law

AUGUST 12, 2021

As a result of this decision, Semglee can now be substituted for Lantus prescriptions without the intervention of a health care provider in accordance with state substitution regulations. Thus, though Semglee is not new to the market, it is for the first time substitutable for Lantus without intervention of a health care provider.

Clinic 98

Clinic Provider IT Patients 98

FDA Law

NOVEMBER 20, 2024

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. Data from chemical characterization studies must be evaluated in a separate TRA following ISO 10993-17 guidelines.

Provider 59

Provider Medical Manufacturing Consulting 59

FDA Law

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ).

Patients 52

Patients Clinic Medical Patient-Centered 52

Aspiring Minority Doctor

MARCH 14, 2022

I was fortunate to know in advance I would not be matching, but having to manage patients and scrub into cases in between going through the process of applying to unfilled programs didn’t make things any better. My story isn’t one of not matching one year and then going on to match the following year. I actually failed to match twice!

Medical Student 52

Medical Student Medical Management IT 52

FDA Law

OCTOBER 30, 2022

This draft guidance proposes updates to FDA’s Breakthrough Devices Program, which is outlined in a separate December 2018 guidance document. FDA intends to incorporate these updates into the December 2018 Breakthrough Devices Program guidance after considering public comment.

Diagnosis 59

Diagnosis Clinic Provider IT 59

FDA Law

AUGUST 2, 2022

Cole providing guidance to U.S. However, in January 2018, then-Attorney General Jeff Sessions rescinded the Cole and Ogden Memos. 21 U.S.C. § 812(b)(1). 3 (July 5, 2022) [hereinafter CRCC Letter]. The “Cole Memo” was a memorandum from General James M. 26, 2022).

Medical 96

Medical Individual Provider Community 96

PEMBlog

APRIL 22, 2025

While we pride ourselves on providing high-quality care for all children, we must acknowledge that the noisy, fast-paced, and unpredictable environment of the ED can be especially distressing for autistic patients. Advocate for transition planning resources as patients age out of pediatric care. 2018 May/Jun;79(3):17r11506.

Family 77

Family Families Patient-Centered Physicals 77

FDA Law

JUNE 23, 2021

Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. By James E. The practice of medicine was viewed as paternalistic.

Patients 52

Patients Patient-Centered Clinic Community 52

The Clinical Problem Solvers

DECEMBER 16, 2020

19:05 Clarifying the “ethics vs science” argument and critiquing research techniques 22:00 Resurgence of race-based speculation in COVID-19-related research 25:57 Implantation of ideas about innate racial inferiority within medicine 28:32 Will removal of race from algorithms potentially harm our patients?

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

FDA Law

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.

Consulting 52

Consulting Medical Management Specialization 52

FDA Law

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 ). Specifically, that it allows for fast production of “patient-matched devices” (i.e.,

Medical 98

Medical Manufacturing Healthcare Government 98

FDA Law

DECEMBER 13, 2023

Janet Maynard, Director of this Office, highlighted in the press release that “[g]enetic metabolic diseases include very rare diseases that individually affect a limited number of patients. Drug development for these conditions has unique and complex challenges, therefore few treatments are available to patients.”

Patient-Centered 59

Patient-Centered Medical Patients IT 59

GeriPal

JUNE 8, 2023

When I’m on palliative care consults and attending in our hospice unit we have to counsel patients about deprescribing and de-intensifying diabetes medications. Our last podcast was with Laura Petrillo in 2018 – 5 years ago seems ancient history – though many of the points still apply today (e.g. Goldilocks zone).

Diabetes 74

Diabetes Management Patient-Centered Family 74

FDA Law

OCTOBER 4, 2022

Reporting these allegations to FDA is important as the Agency may be unaware of the actions of these manufacturers and marketers, thus creating potential risks to patients. Although these allegations can be submitted anonymously, FDA encourages the submitter to provide contact information in case additional background is needed.

Manufacturing 52

Manufacturing Medical Provider IT 52

FDA Law

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 ). Specifically, that it allows for fast production of “patient-matched devices” (i.e.,

Medical 75

Medical Manufacturing Healthcare Government 75

FDA Law

SEPTEMBER 11, 2023

This announcement addresses one of the commitments in FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. Use of the eSTAR template for 510(k)s becomes mandatory on October 1, 2023 (unless exempt as described in the final guidance ).

Medical 64

Medical Electronics Manufacturing Utilities 64

FDA Law

JULY 7, 2021

In March 2020, FDA issued a final rule that banned the use of Graduated Electronic Decelerators (GEDs) to treat patients with severe self-injurious and aggressive behaviors (SIB/AB), but did not restrict the use of these same devices for other purposes, like smoking cessation. FDA cleared 510(k)s for GEDs in the 1990s.

Medical 52

Medical Patient-Centered Patients IT 52

BMJ

JULY 17, 2020

As previous research has found, providing factual information helps tremendously in addressing misconceptions and myths about infectious diseases, the latter of which can seriously undermine implementation of preventive measures. How to reduce the negative psychological impact MRSA isolation on patients. Nurs Times 2010;106(36):14–16.

Community 40

Community Individual Physicals Finance 40

FDA Law

JULY 15, 2021

FDA’s 2018 CFL Guidance seemed to signal to industry that FDA would be more flexible on Rx drug benefit claims. This claim is based on a real world, retrospective study of 11,000 patients, comparing Neulasta PFS and Neulasta Onpro. of Neulasta (pegfilgrastim) misbranding due to false or misleading promotion. Neulasta Onpro).

Healthcare 52

Healthcare IT Provider Patients 52

FDA Law

DECEMBER 11, 2023

This is based on FDA’s reported 2018 review of the CLIA database. [2] This is 50% greater than the 2018 numbers relied upon by FDA in its estimates. [3] Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ).

IT 69

IT Medical Patient-Centered Provider 69

PEMBlog

APRIL 20, 2023

Emicizumab (Hemlibra) was approved in 2018 for routine bleeding prophylaxis in hemophilia A with or without inhibitors. How to know if a patient is on it? Patients on emicizumab will have it listed on their medication list. Patients/caregivers should also be able to tell you if they are on emicizumab (Hemlibra).

Individual 52

Individual Patient-Centered Patients IT 52

FDA Law

FEBRUARY 27, 2023

The Ryan Haight Act did not limit the ability to prescribe controlled substance medications by telemedicine so long as the patient and prescriber had a least one in-person visit. a prescriber that engages in telemedicine with the patient), including a review of PDMP data for the past year. 21 U.S.C. § 802(54)(D)(i).

Telemedicine 59

Telemedicine Telecommunication Telehealth Medical 59

FDA Law

MAY 25, 2022

The safety communication acknowledges that the tests “may provide useful information to assess the risk that a fetus has (or does not have) a genetic abnormality.” However, even with a low PPV, a test can provide clinically useful information to providers and patients.

Provider 40

Provider Screening Medical Patients 40

PEMBlog

MAY 11, 2023

Some general recommendations to reduce pain during LP include: Comfortable Positioning: The patient should be instructed to lie on their side with their knees drawn up to their chest and their chin tucked in, or sit upright with their head and upper back forward (often on a bedside table with a pillow). Is there evidence for the J-Tip?

Patient-Centered 52

Patient-Centered Provider IT Patients 52

FDA Law

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

Manufacturing 52

Manufacturing Government Referral Provider 52

FDA Law

JUNE 16, 2023

The statement must itemize the cost components related to production of the drug, identify increases in materials or manufacturing costs, and provide other information that the manufacturer believes relevant to determining whether a violation has occurred. SF 2744 also provides a private right of action to enforce the prohibition.

Manufacturing 45

Manufacturing Provider Consulting IT 45

CDOCS

MARCH 31, 2021

With the approval of both the patient as well as the practitioner, all materials would be sent back to the lab for the final fabrication& of the prosthesis.¹ & This process can be completed for both or just one arch depending on what the patient needs.& Spear Faculty and Contributing Author.

Appointment 52

Appointment Family Families Patients 52

FDA Law

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. §

Lab Testing 52

Lab Testing Individual Referral Patient-Centered 52

FDA Law

APRIL 14, 2022

De Novo Requests: In the MDUFA IV commitment letter, FDA’s performance goal for review of de novo requests started with review of 50% of requests received in FY 2018 within 150 days of receipt, and increased 10% per fiscal year, ending with 70% within 150 days in FY 2022. By McKenzie E.

Provider 40

Provider Clinic Medical IT 40

FDA Law

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law

FEBRUARY 27, 2024

For years after the enactment of the Hatch-Waxman Amendments the PTO interpreted the PTE statute to permit multiple PTEs, provided there are separate, but not necessarily different, regulatory review periods. 2018) , Arnold Partnership v. leave you scratching your head (we’ll call it “Who’s Buried in Grant’s Tomb?”). 3d 1367 (Fed.

Patients 59

Patients IT Provider Individual 59

FDA Law

MAY 17, 2022

FDA approved FIRDAPSE in November 2018, with a period of orphan drug exclusivity, for the treatment of Lambert-Eaton Myasthenic Syndrome (“LEMS”) in adult patients. Usually FDA’s lobbying activities are done rather quietly. Usually FDA’s lobbying activities are done rather quietly. Becerra.” and more likely 15-20.

IT 40

IT Patients Provider Individual 40