Reflections of a Grady Doctor

APRIL 24, 2019

In 1992, I started at Meharry Medical College--the school that felt right but that I feared attending because, after Tuskegee University, it would be my second historically black college. I took the interview there only because it coincided with my interview at The Cleveland Clinic. Got an interview there. And never came off the list.

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My Green Doctor

APRIL 4, 2025

New Research: Teaching Patients about Climate Resilience Newly published original research co-authored by My Green Doctor’s Dr. Todd Sack concludes that, “ the medical office waiting room appears to be an accepted, time-efficient, and effective site to communicate knowledge on climate change and health. ” Contact us today!

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The Clinical Problem Solvers

OCTOBER 23, 2019

Her clinical interests include mental health disease, hepatology and functional gastroenterology. He is a graduate of Boston College and obtained his dual MD/MPH from Rutgers New Jersey Medical School. His clinical interests include atrial fibrillation and medical education. Human Dx Learn more here

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FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). products intended for medical purposes).

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The Clinical Problem Solvers

MARCH 24, 2020

Schema Human Dx Case Download CPSolvers App here Patreon website Dr. Himali Gandhi I graduated from NYU medical school and am now finishing my PGY-3 year at Montefiore Medical Center in the Bronx, NY. Alex Hajduczok Alex Hajduczok is a second-year internal medicine resident at Penn State Hershey Medical Center.

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The Medical Futurist

JUNE 21, 2025

However, things are moving fast, and success doesn’t come easy for the pioneers of any medical field. Their research showed promising results for lab rats, and they plan to carry out the first human trials in the second half of 2017 and gather preliminary results during 2018. Cyborgization is upon us?

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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 ). Valentine & Larry J.

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PEMBlog

OCTOBER 31, 2024

However, this large study shows that probiotics do not significantly shorten illness duration, improve symptoms, or reduce the need for additional medical visits. 2018 Nov 22;379(21):2002-2014. N Engl J Med 2018; 379:2015-2026. By using the latest research, parents can focus on more effective treatments like hydration.

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The Clinical Problem Solvers

OCTOBER 18, 2022

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. Correctional officers act as gatekeepers, deciding who does and does not need medical care. 2018 Sep;142(3):e20174314. Epub 2018 Jul 9. Pediatrics. doi: 10.1542/peds.2017-4314.

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FDA Law Blog

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.” By Jeffrey N.

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FDA Law Blog

JANUARY 18, 2022

Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. products intended for medical purposes). products intended for medical purposes).

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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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Medical Xpress

DECEMBER 2, 2022

During a routine visit to the Good Samaritan Clinic in Morganton, North Carolina, in 2018, Herbert Buff casually mentioned that he sometimes had trouble breathing.

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The Clinical Problem Solvers

JANUARY 18, 2021

Harvard Medical School Primary Care Blog. Creating a segregated medical profession: African American physicians and organized medicine, 1846-1910. Medical Care. A Historic Day For Black Women, A Historic Day For The American Medical Association. American Medical Association. American Medical Association.

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Medical Xpress

JANUARY 27, 2023

She researched rural states facing a shortage of behavioral health providers and accepted a job as a lead clinical primary therapist at Shodair Children's Hospital in Helena, Montana, in January 2018.

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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.,

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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.

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FDA Law Blog

OCTOBER 5, 2022

eSTAR will prompt for attachments when necessary; this includes financial certifications and disclosure statements for the section of clinical testing. eSTAR will be mandatory October 1, 2023 for all 510(k) submissions and subsequent supplements and amendments (e.g. add-to-files). (A eSTAR submissions are automated (e.g.,

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FDA Law Blog

AUGUST 4, 2022

In September 2020, the Agency issued an unfavorable advisory opinion to Pfizer, concluding that the proposal was “highly suspect” under the AKS “because one purpose of the [proposed program]—perhaps the primary purpose—would be to induce Medicare beneficiaries to purchase [Pfizer’s] federally reimbursable Medications.”

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PEMBlog

APRIL 22, 2025

Discuss options like oral medications, intranasal routes, or the presence of trusted caregivers during procedures. What you can do: Partner with outpatient providers to ensure follow-up is arranged for behavioral, medical, or developmental concerns. Medical Management of Children With Autism in the Emergency Department.

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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.

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FDA Law Blog

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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FDA Law Blog

DECEMBER 16, 2024

Lenz, Principal Medical Device Regulation Expert FDA recently released 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which finalizes the draft guidance of the same title issued in December 2023. The Agency has reportedly been trying to improve the program, as we discussed in 2018 and 2020.

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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! I even bought one for my little sister since I like it so much!

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Electronics Healthcare Professional IT Medical Student 52

FDA Law Blog

FEBRUARY 27, 2023

The Ryan Haight Act was enacted to address the legal “grey area” in which prescribers and pharmacies operated via the creation of two new statutory requirements: 1) the at least one “in-person” medical evaluation requirement for prescribing practitioners, 21 U.S.C. § 829(e); and 2) the modified registration requirement for online pharmacies.

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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. §

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FDA Law Blog

JUNE 29, 2022

For CDER specifically, the division must discuss the proposed rescission with CDER’s Medical Policy Council prior to notifying the sponsor. The Medical Policy Council’s role, as described in the MAPP, is to discuss decisions to rescind to ensure consistency in policy implementation across review divisions. randomization, blinding).”

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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] 11] In fact, in Fiscal Years 2018 – 2022, fewer than 100 510(k)s went through the Third-Party Review Program annually. [12] of 510(k) decisions, respectively. [13]

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FDA Law Blog

JUNE 23, 2021

I have witnessed it inform whether clinical trial results are clinically meaningful (or not) as well as the selection and even development of primary endpoints. Cavazzoni lays out is the traditional way in which patients have informed drug benefit-risk decision-making: by setting the “clinical context” of the disease.

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FDA Law Blog

APRIL 14, 2022

Cato — On March 22, FDA announced that it reached agreement with representatives from the medical device industry on proposed recommendations to Congress for the fifth reauthorization of the Medical Device User Fee Amendments (MDUFA V). During the pilot, over 85 testing laboratories have become ASCA accredited (see list here ).

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FDA Law Blog

MAY 25, 2022

Indeed, the communication identifies several medical societies (the American College of Obstetricians and Gynecologists (ACOG), the Society for Maternal-Fetal Medicine (SMFM), and the American College of Medical Genetics and Genomics (ACMG)) that recommend use of these types of tests as part of standard prenatal care.

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FDA Law Blog

OCTOBER 25, 2021

The Medical Device Amendments of 1976 created the initial premarket application (PMA) review and 510(k) substantial equivalence review processes. befitted a very important pathway to market for novel medical devices. Shapiro — After 23 years, de novo classification review finally has an implementing regulation ! Part 860.

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The Clinical Problem Solvers

AUGUST 25, 2020

Trainees may use this foundation to question how this might impact their medical education and think about this educational legacy may be reformed through curricular and structural changes at their institutions. The Clinical Problem Solvers Podcast. Essien, MD, MPH Hosts: Dereck Paul, MS, Utibe R. N Engl J Med 2020; 383:197-199.

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Community Patient-Centered Relationship Education 52

Pamela Wible MD

JUNE 20, 2025

(Published 3/18/19, updated 6/20/25) What Is Physician “Burnout”—and Why It Matters Physician “burnout” is a state of emotional, physical, and mental exhaustion caused by prolonged stress in the medical workplace. and it has been linked to rising rates of physician depression , doctor suicide , and medical errors.

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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., electronic formatting for regulatory submissions), scientific (e.g.,

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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. §

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FDA Law Blog

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. By Philip Won & Adrienne R.

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