GeriPal

MAY 5, 2022

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? Lastly, I also just want to give a shout out to the last article above which also includes this lovely checklist of methods to address hearing loss in clinical encounters. I’m guessing not. Transcript.

IT 102

IT Screening Hospital Clinic 102

FDA Law

MARCH 31, 2024

Karcher testified that it is not clear how this assessment was done and that even CAP doesn’t have the capability to gather such information. As we previously blogged , the draft final LDT rule is with OMB’s Office of Information and Regulatory Affairs (OIRA) for review. The FDA proposed rule elicited some strong criticism.

Patients 64

Patients Medical Provider Manufacturing 64

FDA Law

MARCH 6, 2025

We were struck by the level of detail expected by FDA for processes related to data management, especially for data collected and used early in development to train an initial AI model, which may occur before a manufacturer decides to move forward with device development under design controls. data acquisition device).

Manufacturing 105

Manufacturing Management Clinical Practice Clinic 105

FDA Law

OCTOBER 16, 2024

There, as we explained back in July , Novartis argued that FDA’s approval of a generic ENTRESTO with indication information modified rather than simply omitted “represents a sharp departure from FDA’s statutory and regulatory mandate to require that a generic drug be the ‘same’ as its reference listed drug.”

Manufacturing 98

Manufacturing Patients IT Hospital 98

FDA Law

SEPTEMBER 30, 2024

CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. pricing, among other things.

Manufacturing 59

Manufacturing Utilities Provider IT 59

FDA Law

AUGUST 7, 2024

On July 30, brand name drug sponsor Novartis asked the District Court for a Temporary Restraining Order ( here and here ) enjoining FDA’s approval of a generic version of its ENTRESTO (sacubitril and valsartan) with certain dosing and indication information carved-out or modified.

Manufacturing 59

Manufacturing Hospital Patients IT 59

FDA Law

OCTOBER 17, 2023

Non-Addictive Medical Products to Treat Pain or Addiction The SUPPORT Act ( Public Law 115-271 ) mandated that FDA issue a guidance document to provide information on how the Agency can apply section 515B of the FD&C Act to non-addictive medical products intended to treat pain or addiction.

Medical 53

Medical Diagnosis Healthcare Clinic 53

GeriPal

MAY 8, 2025

We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. Alex 00:33 Our next guest is Margaret Ross, who’s a clinical psychologist and researcher at St. Vincent’s Hospital in Melbourne, Australia.

Illness 107

Illness IT Patient-Centered Patients 107

GeriPal

MARCH 24, 2022

Ideally, there’ll be a place in the chart that actually captures the name of that person and their contact information. So a lot of the skills that are used in advance care planning are the same kind of skills you would use in a context where you were communicating information or prognosis or doing an informed consent discussion.

Illness 72

Illness IT Healthcare Patient-Centered 72

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. For providers, it is highly encouraged to submit samples from hospitalized patients to a laboratory capable of identifying H5N1 if influenza is confirmed in the inpatient setting and H5N1 is suspected. link] [link]

Patient-Centered 130

Patient-Centered Provider Manufacturing Screening 130

FDA Law

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.” NPRM at 44,607. Basis at 7-8; NPRM at 44,614.

Physicals 69

Physicals Medical Clinic Emergency Room 69

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. We really do not.

Healthcare 129

Healthcare IT Education Community 129

FDA Law

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 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.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98