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

Common Sense Family Doctor

APRIL 12, 2025

Although on the surface these are unchanged from the 2018 version —recommending screening in all women 65 years or older and postmenopausal women younger than 65 years at increased risk for an osteoporotic fracture and finding insufficient evidence to screen men—an accompanying editorial noted a small, but significant, difference.

Screening 52

Screening Family Physician Clinic Community 52

The Clinical Problem Solvers

OCTOBER 18, 2022

All healthcare professionals will have patients who are directly or indirectly impacted by the carceral system. Our guests remind us to think critically about our role in the carceral system and in imposing systems of control and punishment within clinical settings.

Healthcare Professional 52

Healthcare Professional Healthcare Patient-Centered Mental Health 52

FDA Law Blog

FEBRUARY 16, 2022

In 2009, Catalyst’s drug Firdapse (amifampridine phosphate) received Orphan Drug Designation for Lambert-Eaton Myasthenic Syndrome (“LEMS”), and FDA subsequently approved Firdapse in November 2018 for the treatment of LEMS in adults with 7 years of Orphan Drug Exclusivity.

Clinic 98

Clinic Patients IT 98

FDA Law Blog

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 Blog

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

PEMBlog

OCTOBER 31, 2024

Why is this important for patients and caregivers ? A brief message from the principal investigator We studied close to a thousand patients with acute gastroenteritis in ten U. A brief message from the principal investigator We studied close to a thousand patients with acute gastroenteritis in ten U. hospitals. N Engl J Med.

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Hospital Illness Patients Provider 105

FDA Law Blog

JULY 17, 2024

We also commend and congratulate the legions of rare disease patient advocates and the leadership of the EveryLife Foundation for Rare Diseases (“ELF”) who championed the advocacy efforts that led to this important milestone. By Sarah Wicks & James E. Valentine & Frank J.

Patient-Centered 105

Patient-Centered Community Medical Specialty Clinic 105

FDA Law Blog

AUGUST 12, 2021

Biosimilars do provide a more affordable way for sponsors to get products onto the market—by referencing the clinical studies performed by the reference product sponsor—which, in theory, allows for the introduction of lower cost versions of expensive biologics. As FDA states in its Press Release, “Biosimilars marketed in the U.S.

Clinic 98

Clinic Provider IT Patients 98

GeriPal

MAY 19, 2022

A patient is on morphine and you want to convert it to another opioid like hydromorphone (dilaudid). Dr. Akhila Reddy and colleagues study looking at converting hospitalized cancer patients from IV hydromorphone to PO morphine, PO hydromorphone, or PO oxycodone. Summary Transcript Summary. How do you do that? Mary Lynn: Thank you.

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IT Patients Individual Relationship 139

FDA Law Blog

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 Blog

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

FDA Law Blog

AUGUST 4, 2022

Recognizing that this out-of-pocket cost still represents a significant financial barrier for many patients, Pfizer proposed a Direct Copay Assistance Program for Medicare Part D beneficiaries using tafamidis. Pfizer, Inc. Department of Health and Human Services et al. July 25, 2022. Pfizer appealed to the Second Circuit.

Manufacturing 98

Manufacturing Medical Government IT 98

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. The Journal of Clinical Psychiatry.

Families 77

Families Family Patient-Centered Physicals 77

33 Charts

FEBRUARY 24, 2022

It comes from Automattic engineer Mike Shelton in 2018. Industrialized healthcare positions patients as units in clinical workflows. If you like The People Margin you might like our Clinical Industrialization Archives. I love this concept of the people margin. Shelton wasn’t talking about medicine but he could have been.

Engineering 45

Engineering Healthcare Clinic IT 45

FDA Law Blog

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

Aspiring Minority Doctor

DECEMBER 8, 2021

I also love wearing my Medelita Kinetic Scrub Jacket especially since the hospitals and clinics are so cold. ProCompression Socks Throwback pic from one of my 2018-2019 24hr call shifts I swear by Pro Compression socks! Happy December! Can you believe Christmas is only 17 days away?!?! Plus they smell amazing! I use black in 0.7

Electronics 52

Electronics Healthcare Professional IT Medical Student 52

FDA Law Blog

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 ). In a statement released at the time, CDRH Director Jeffrey Shuren, M.D.,

Medical 64

Medical Electronics Manufacturing Utilities 64

PEMBlog

SEPTEMBER 24, 2024

At that point, he was referred to pulmonology who started the patient on albuterol, manual chest physiotherapy, and a steroid inhaler with a plan for a fourth chest x-ray four weeks later. On arrival, the patient was febrile to 38.3C. Bronchopulmonary sequestration Our patient was diagnosed with bronchopulmonary sequestration (BPS).

Diagnosis 52

Diagnosis Diagnose Patients Asthma 52

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 Blog

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

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 Blog

AUGUST 29, 2021

This policy, announced by then Associate Attorney General Rachel Brand in 2018 was referred to as the Brand Memo. clinical testing of implanted brain computer interface devices for patients with paralysis or amputation), enforcement (e.g., Sometimes they do it with great fanfare; sometimes it is done quietly and incrementally.

Government 52

Government Electronics IT Clinic 52

FDA Law Blog

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 Blog

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 Blog

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

FDA Law Blog

MAY 25, 2022

The communication, however, warns patients and healthcare providers of the potential of NIPT to produce erroneous results, particularly false positive results (“these tests can give false results, such as reporting a genetic abnormality when the fetus does not actually have one”). This is – of course – not the intended use of these tests.

Provider 40

Provider Screening Medical Patients 40

The Clinical Problem Solvers

AUGUST 25, 2020

Policing in Schools and Hospitals Health care systems must actively advocate and protect their patients and that means we have to also reevaluate the presence of police in our spaces. Essien, MD, MPH Hosts: Dereck Paul, MS, Utibe R. This includes thinking about our roles as mandated reporters and police presence in emergency departments.

Community 52

Community Patient-Centered Relationship Education 52

FDA Law Blog

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

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 Blog

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 Blog

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 Blog

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 Blog

JUNE 16, 2023

The Board is not required to identify all drugs that meet the above criteria and may, in consultation with the advisory council and the commissioner of health, identify drug products that fall outside these criteria but otherwise could create “significant affordability challenges” for Minnesota’s healthcare system or Minnesota patients.

Manufacturing 45

Manufacturing Provider Consulting IT 45

FDA Law Blog

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 Blog

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

Pamela Wible MD

JUNE 20, 2025

During that time, psychologist Herbert Freudenberger volunteered at a New York City free clinic treating addiction. He overheard the term and used it to describe himself and clinic staff in a 1974 article on staff burnout detailing long-term physical and psychological job stress. So what’s the real issue? Now we’re getting somewhere.

Medical Student 246

Medical Student Diagnosis Physicals Medical 246