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 52

Patient-Centered Patients Manufacturing Provider 52

FDA Law

DECEMBER 15, 2024

In this post we focus in on the draft guidance documents chemistry, manufacturing, and controls (CMC)-specific content. In general, a greater understanding and knowledge of the product and manufacturing process can reduce the number of PPQ lots that should be sufficient to qualify the performance of the manufacturing process.

Manufacturing 52

Manufacturing Engineering Patient-Centered Provider 52

FDA Law

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 52

Patient-Centered Healthcare Manufacturing Provider 52

FDA Law

JANUARY 5, 2023

To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

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

OCTOBER 6, 2023

The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. Change to the IVD definition First, the mechanics of the change.

Provider 64

Provider Manufacturing IT Medical 64

FDA Law

AUGUST 7, 2023

By Véronique Li, Senior Medical Device Regulation Expert — The Center for Devices and Radiological Health (CDRH) offers learning opportunities for new and experienced CDRH staff through the Experiential Learning Program (ELP). It was also helpful to hear first-hand the practical challenges companies navigate in bringing products to market.

Patient-Centered 40

Patient-Centered Insurance Manufacturing Provider 40

FDA Law

OCTOBER 12, 2022

Most states have some form of naloxone standing order that allows a healthcare provider to write a prescription that covers a large group of people rather than just an individual patient. syringes), to any individual without a patient-specific prescription. plies for administration (e.g.,

Supply Chain 52

Supply Chain Individual Provider Patient-Centered 52

FDA Law

DECEMBER 11, 2023

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 ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It

IT 69

IT Medical Patient-Centered Provider 69

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 107

Illness IT Patient-Centered Patients 107

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

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. All decisions are made in advance, the question that we are debating is how far in advance and what to call it.

Illness 72

Illness IT Healthcare Patient-Centered 72

FDA Law

JANUARY 18, 2024

FDA’s Center for Drug Evaluation and Research Controlled Substances Staff conducts the scheduling analysis and makes recommendations. By doing so, FDA determined that marijuana not only no longer meets schedule I criteria, but by leapfrogging to schedule III, concluded that it does not meet schedule II criteria either. 21 U.S.C. §

Medical 69

Medical Physicals IT Healthcare Professional 69

FDA Law

JUNE 14, 2023

Also, it is unclear which office within CDRH appoints the TAP Advisor, e.g., center-level, OPEQ-level, or division-level. Also, it is unclear which office within CDRH appoints the TAP Advisor, e.g., center-level, OPEQ-level, or division-level. It remains to be seen how FDA would define and actually implement the role of a TAP Advisor.

Manufacturing 45

Manufacturing Medical Appointment Patient-Centered 45

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 129

Healthcare IT Education Community 129

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 130

Patient-Centered Provider Manufacturing Screening 130

FDA Law

MAY 21, 2024

Scientific Evidence of Marijuana’s Pharmacological Effects, If Known HHS found that marijuana abuse can lead to negative consequences that include addiction and the need for medical attention through poison center calls or emergency room visits. and lacked accepted safety for use under medical supervision. 21 U.S.C. § 21 U.S.C. §

Physicals 69

Physicals Medical Clinic Emergency Room 69

FDA Law

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. Mullen & Jeffrey N. It did not.

Patient-Centered 102

Patient-Centered Consulting Government Clinic 102

FDA Law

NOVEMBER 8, 2022

For whose manufacturers who do not intend to continue device distribution, FDA generally does not intend to request market removal of those devices distributed before the applicable EUA termination or guidance withdrawal date. Dr. Baron spoke to specific actions sponsors can take to improve representation of women in cardiac clinical trials.

Medical 59

Medical Manufacturing Patient-Centered Provider 59

FDA Law

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. Last Thursday, the U.S.

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Manufacturing Supply Chain Patient-Centered Utilities 98