Common Sense Family Doctor

DECEMBER 14, 2024

Concerns about overdiagnosis of clinically insignificant prostate cancer through prostate specific antigen (PSA) screening motivated the 2018 American Academy of Family Physicians’ (AAFP) recommendation against routine screening for prostate cancer. Watchful waiting refers to clinical observation only. and 6.1%, respectively).

Routine Screenings 52

Routine Screenings Screening Complication Diagnose 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

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

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. RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.”

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. FDA suggests that simulated use/leachables studies to simulate the clinical use (i.e.,

Provider 59

Provider Medical Manufacturing Consulting 59

PEMBlog

OCTOBER 18, 2024

The condition affects multiple organ systems—muscular, cardiac, and respiratory—leading to a myriad of clinical complications. When patients with DMD present in the Emergency Department (ED), an understanding of the nuanced aspects of their care is essential for optimal management.

Patients 52

Patients Complication Management Consulting 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

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

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.

Families 77

Families Family Patient-Centered Physicals 77

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

SEPTEMBER 11, 2023

This announcement addresses one of the commitments in FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs.”

Medical 64

Medical Electronics Manufacturing Utilities 64

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

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

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.& Take clinical photos (7)<br /> 4.

Appointment 52

Appointment Families Family 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 Referral Individual Patient-Centered 52

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

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

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. We are, certainly, supportive of this effort.

Provider 40

Provider Clinic Medical IT 40

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

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). for the lidocaine group and 4.8 (0.5)

Patient-Centered 52

Patient-Centered Provider IT Patients 52

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 Families 74

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

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] Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations.

IT 69

IT Medical Patient-Centered Provider 69

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 40

Lab Testing Individual Referral Patient-Centered 40

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. And UFA reauthorization provides the perfect vehicle for the Agency to try and get this accomplished. and more likely 15-20. and more likely 15-20. Becerra.”

IT 40

IT Patients Provider Individual 40

Physician's Weekly

JUNE 19, 2025

On Fridays, Stephanie Johnson has a busy schedule, driving her navy-blue Jeep from one patient’s home to the next, seeing eight in all. Forget a lunch break; she often eats a sandwich or some nuts as she heads to her next patient visit. “Our patient isn’t just the older adult,” Johnson said. “Hello.

Nurse Practitioner 52

Nurse Practitioner Families Family Primary Care 52

The Clinical Problem Solvers

FEBRUARY 8, 2023

A more Western perspective on health care emphasizes the role of physicians and health care providers and marginalizes the role and contributions of doulas and midwives. Jordan then questions the utility and continued operation of methadone clinics, especially as the United States largely moves on from the COVID-19 pandemic.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

FDA Law

JANUARY 4, 2023

By Dara Katcher Levy — A win for patient access! Prescription drug and medical device Pre-Approval Information Exchange (PIE) now has specific legal protection allowing for sponsors to proactively communicate to payors certain information about products in development to help expedite patient access upon product approval.

Patients 64

Patients Provider IT Utilities 64

Physician's Weekly

JUNE 19, 2025

Due to the inclusion of multiple variables, guiding patients on diet based on DII becomes more complex.” Independent Association The study involved analysis of data from 43,842 adults in the National Health and Nutrition Examination Survey (NHANES, 1999-2018).

Hypertension 52

Hypertension Individual Diabetes Diagnose 52

GeriPal

SEPTEMBER 7, 2023

Does it improve outcomes that patients, caregivers, and clinicians care about? hint: 80% can be done in advance by patients or caregivers) Why is it that some oncologists are resistant to conducting a geriatric assessment, yet have no problem ordering tests that cost thousands of dollars? Welcome back, William. William: Thanks so much.

Patient-Centered 129

Patient-Centered IT Patients Clinic 129

GeriPal

OCTOBER 24, 2024

If you believe the evidence for efficacy to manage symptoms like neuropathic pain, how do you even start to think about recommending these products to patients? And then I met a patient in clinic once who asked me a lot of really intelligent questions about medical cannabis, what it does. They just kept at it.

Medical 99

Medical IT Patient-Centered Healthcare 99

Physician's Weekly

JUNE 11, 2025

The systematic review of peer-reviewed intervention was published from 2018 to 2023. An Outside Expert Shares Her Perspective Nadine Harris, MD , who was not involved in the study, spoke with Physician’s Weekly ( PW ) about the results and ways to provide optimal care to Black women with HIV.

Mental Health 114

Mental Health Healthcare Professional Community Healthcare 114

BMJ

FEBRUARY 8, 2021

Two out of three drug overdose deaths in 2018 involved an opioid – be it prescription opioids, heroin, or synthetic opioids. 6 As a result of these and many other actions, the death toll from opioid overdose fell by more than 4% between 2017 and 2018. 2 Opioids contribute a large share of this overdose crisis.

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Medical Holistic Care Healthcare Healthcare Professional 40

GeriPal

FEBRUARY 15, 2024

The insight started when Carmen, an orthopedic surgeon-researcher, and Katie, a physical therapist- researcher participated in ride-alongs with EMS providers to patient’s homes. Going into patient’s homes was eye opening. And yet, after assisting the older adult to their feet, the EMS providers would leave.

Community 115

Community Transportation IT PCP 115

GeriPal

MARCH 2, 2023

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. There are a lot of reasons that may explain the massive increase in use of these drugs.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96