Clinic, Information, Manufacturing and Patient-Centered

The Future Of Vision And Eye Care

The Medical Futurist

JUNE 21, 2025

Compared to that, our hearing only processes 11 percent of information, while smell 3.5 In 2015, surgeons in Manchester, UK have performed the first bionic eye implant for an AMD patient using Second Sight’s innovation. Experts even say the eye is an ideal place to start for the first clinical use of CRISPR. percent, touch 1.5

Diabetes

Diabetes Patient-Centered IT Patients

Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

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

Patients Clinic Medical Patient-Centered

OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and controls (CMC).

Manufacturing

Manufacturing Engineering Clinic Provider

Interdisciplinary Case Report

CDOCS

MAY 4, 2021

Without this additional skill set and post graduate training I simply could not deliver the results that my patients deserve. We need to recognize how clinical dentistry has become intertwined with digital technologies to synergistically assist us in providing enhanced diagnosis with safe and predictable treatment outcomes. &

Patient-Centered

Patient-Centered Patients Manufacturing Clinic

Urinary Incontinence Revisited: George Kuchel & Alison Huang

GeriPal

JUNE 20, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

IT

IT Patient-Centered Patients Clinic

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

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

Patient-Centered Manufacturing Clinic Provider

FDA Issues Unsupported Safety Warning Regarding Surgical Robots for Cancer Treatment

FDA Law Blog

OCTOBER 14, 2021

Mullen — In recent years, for novel robot assisted surgery (RAS) devices, FDA’s Center for Devices and Radiological Health (CDRH) has taken the approach of clearing RAS devices for specific indications for use. Rather, FDA seems intent on regulating RAS devices almost as if they were therapeutics responsible for long term clinical outcomes.

Patient-Centered

Patient-Centered Healthcare Provider Manufacturing

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. James 00:32 Good afternoon.

Illness

Illness IT Patient-Centered Patients

“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program

FDA Law Blog

JUNE 14, 2023

He highlighted the following key features of TAP: An Innovative Approach To provide proactive support and guidance to medical device manufacturers, FDA has introduced a new CDRH position known as the “TAP Advisor.” Also, it is unclear which office within CDRH appoints the TAP Advisor, e.g., center-level, OPEQ-level, or division-level.

Manufacturing

Manufacturing Medical Patient-Centered Appointment

Advance Care Planning Discussion: Susan Hickman, Sean Morrison, Rebecca Sudore, and Bob Arnold

GeriPal

MARCH 24, 2022

Alex: We are delighted to welcome to the GeriPal podcast, Susan Hickman, who is professor at the Indiana University schools of nursing and medicine, and is director of the IU Center for Aging Research at the Regenstrief Institute. Welcome to the GeriPal podcast Susan. Susan: Thanks so much, Alex. I think Bob also noted documenting it.

Illness

Illness IT Healthcare Patient-Centered

A Review of H5N1

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

The Alabama Department of Public Health and the Alabama Department of Agriculture and Industries, along with the Centers for Disease Control and Prevention, the United States Food and Drug Administration, and the United States Department of Agriculture are monitoring this situation very closely and hold regular meetings on the subject.

Patient-Centered

Patient-Centered Provider Manufacturing Screening

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

FDA Law Blog

MAY 21, 2024

For each factor, the NPRM noted that DEA’s position is that additional information during the rulemaking will further inform about the appropriate schedule for marijuana. The NPRM noted that DEA “has not yet made a determination as to its views of the appropriate schedule for marijuana.” Basis at 18; NPRM at 44,605. Basis at 24.

Physicals

Physicals Medical Clinic Emergency Room

Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

GeriPal

DECEMBER 7, 2023

AlexSmithMD Additional links: JAMA paper on clinical research risks, climate change, and health Geriatric medicine in the era of climate change Health Care Without Harm: [link] Practice Green Health: [link] Global Consortium for Climate and Health Education: [link] Transcript Eric: Welcome to the GeriPal podcast. Ruth, welcome to GeriPal.

Healthcare

Healthcare IT Education Community

Decades of LDT Tension Leads to an Epic Three-Hour Oral Argument

FDA Law Blog

FEBRUARY 20, 2025

On February 19, 2025, Judge Sean Jordan in the Eastern District of Texas heard oral arguments in American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathologys (AMP) [1] lawsuit against the Department of Health and Human Services. Department of Justice counsel strongly defended the rule throughout the hearing.

Patient-Centered

Patient-Centered Consulting Government Clinic

MedTech Conference Download

FDA Law Blog

NOVEMBER 8, 2022

If you have a good relationship with the review team, Dr. Maisel encourages a brief phone call or quick email to obtain informal feedback. In closing, he advised manufacturers who plan to market their products beyond the public health emergency to plan to submit marketing applications.

Medical

Medical Manufacturing Patient-Centered Provider

Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

FDA Law Blog

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.

Manufacturing

Manufacturing Supply Chain Patient-Centered Utilities

Primary Care Digest

The Future Of Vision And Eye Care

Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

Trending Sources

OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

Interdisciplinary Case Report

Urinary Incontinence Revisited: George Kuchel & Alison Huang

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Issues Unsupported Safety Warning Regarding Surgical Robots for Cancer Treatment

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program

Advance Care Planning Discussion: Susan Hickman, Sean Morrison, Rebecca Sudore, and Bob Arnold

A Review of H5N1

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

Decades of LDT Tension Leads to an Epic Three-Hour Oral Argument

MedTech Conference Download

Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

Stay Connected