Manufacturing, Patient-Centered, Presentation and 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

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

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. These clearances are based on short-term (30 day) patient follow up. By Jeffrey K. Shapiro & Allyson B.

Patient-Centered

Patient-Centered Healthcare Provider Manufacturing

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

A Final LDT Rule in April!? Will FDA be prepared?

FDA Law Blog

DECEMBER 11, 2023

FDA also does not take into account the volume of pre-submissions that laboratories will inevitably need to begin filling almost immediately after issuance of the final rule to ensure that the data they will be presenting to FDA in their premarket submissions is what the Agency will expect. Certain points are indisputable.

IT

IT Medical Patient-Centered Provider

It Takes Three [Components] to Make a Thing Go Riiiiiight – OPDP Challenges Two-Part Ad

FDA Law Blog

JANUARY 26, 2022

Speaking from a bit of experience, this has led to countless field direction memos instructing sales reps on how to pivot from their opening disease awareness presentations to their product details in an effort to keep these two types of communications separate. Creating TV commercials ain’t cheap nor is the air time for them.

IT

IT Education Utilities Patient-Centered

Supreme Court Makes Quick, Unanimous Work of Seventh Circuit’s Interpretation of False Claims Act Scienter Requirement

FDA Law Blog

JUNE 7, 2023

In this case, the Supreme Court provided greater clarity on how to interpret that requirement. In SuperValu , whistleblowers accused the two nationally known retail pharmacies of overbilling the Centers for Medicaid and Medicare Services (CMS) for reimbursements for prescription drugs.

Government

Government Patient-Centered IT 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. Then fast forward a year.

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

This is about reducing the time and cost and increasing the predictability of going from concept to commercialization.” – Dr. Jeff Shuren During a presentation at the May 17, 2023 Food and Drug Law Institute (FDLI) Annual Conference, CDRH Director, Dr. Jeff Shuren discussed TAP with enthusiasm.

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. That’s not unique to POLST as an order.

Illness

Illness IT Healthcare Patient-Centered

A Review of H5N1

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

This influenza infection primarily presents in cattle as decreased milk production, lethargy, and decreased appetite. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. Several commercial laboratories are providing this service including Quest, LabCorp, ARUP and Mayo.

Patient-Centered

Patient-Centered Provider Manufacturing Screening

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

FDA Law Blog

MAY 21, 2024

The Attorney General also released DOJ’s Office of Legal Counsel (“OLC”) opinions providing the rationale and support for the NPRM. The Attorney General, after considering HHS’ recommendations, “concludes that there is, at present, substantial evidence that marijuana does not warrant control under schedule I.” 44,597 (May 21, 2024).

Physicals

Physicals Medical Clinic Emergency Room

Patient Groups Sue HHS, CMS for 2020 Rule Allowing the Use of Copay Accumulator Programs

FDA Law Blog

SEPTEMBER 8, 2022

Wasserstein — Three patient advocate groups have sued the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS), challenging HHS’s 2020 Notice of Benefits and Payment Parameters (NBPP) rule. The patient, on the other hand, is no closer to meeting their deductible than before.

Insurance

Insurance Patients Manufacturing Patient-Centered

MedTech Conference Download

FDA Law Blog

NOVEMBER 8, 2022

Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF). To paraphrase from our blog post , EUAs are triggered by an EUA declaration; FDA will publish advanced notice for an EUA declaration and provide a 180 day notice before the implementation of the transition plan.

Medical

Medical Manufacturing Patient-Centered Provider

Primary Care Digest

Interdisciplinary Case Report

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

Trending Sources

FDA Issues Unsupported Safety Warning Regarding Surgical Robots for Cancer Treatment

Urinary Incontinence Revisited: George Kuchel & Alison Huang

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

A Final LDT Rule in April!? Will FDA be prepared?

It Takes Three [Components] to Make a Thing Go Riiiiiight – OPDP Challenges Two-Part Ad

Supreme Court Makes Quick, Unanimous Work of Seventh Circuit’s Interpretation of False Claims Act Scienter Requirement

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

Patient Groups Sue HHS, CMS for 2020 Rule Allowing the Use of Copay Accumulator Programs

MedTech Conference Download

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