FDA Law Blog

MAY 3, 2021

The CSA establishes a closed system of controlled substance distribution that requires every entity in the chain, from importers to manufacturers, distributors, exporters, pharmacies, hospitals, narcotic treatment programs and practitioners, to obtain a DEA registration and account for the controlled substances they handle.

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Management Manufacturing Specialization IT 52

FDA Law Blog

MARCH 31, 2024

Donald Karcher, president of the College of American Pathologists, said most LDTs are developed and used for patients that are cared for in the hospital or health care network where the lab is located, which enables the lab and pathologists to interact directly to adequately assess the clinical validity.

Patients 64

Patients Medical Provider Manufacturing 64

FDA Law Blog

MAY 3, 2021

The CSA establishes a closed system of controlled substance distribution that requires every entity in the chain, from importers to manufacturers, distributors, exporters, pharmacies, hospitals, narcotic treatment programs and practitioners, to obtain a DEA registration and account for the controlled substances they handle.

Management 40

Management Manufacturing Specialization IT 40

FDA Law Blog

OCTOBER 10, 2022

The final guidance therefore may have significant implications for a wide range of stakeholders, including not only software developers but also health care providers, hospitals, patients and payors. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

Clinic 52

Clinic Medical Provider Patients 52

FDA Law Blog

OCTOBER 2, 2024

On the other hand, the Draft Guidance states that a significant change to the design of a printed circuit board (PCB) in a multi-parameter physiological patient monitor, with arrhythmia detection alarms for use in a hospital environment, would not be appropriate for inclusion in a PCCP. Draft Guidance at 4. Draft Guidance at 34.

Medical 59

Medical Specialization Manufacturing IT 59

GeriPal

MAY 5, 2022

And when you think about that, they’re hearing pieces of the information and their brain is trying to make sense of it. Including more hospital utilization or healthcare utilization, maybe cognitive impairment issues. My own work focuses on hospitalization and health utilization over time. Is that right?

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IT Screening Hospital Clinic 102

FDA Law Blog

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

Alabama Academy of Family Physicians

FEBRUARY 19, 2025

Running from February 4 to May 15, this session promises to bring substantial changes to medical consent laws, Medicaid coverage, rural hospital funding, taxation on essential goods, and the transparency of healthcare costs. HB 86 – Rural Hospital Investment Fund Bill What’s in the Bill: Sponsored by Rep.

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Insurance Management Hospital Vaccination 130

FDA Law Blog

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.”

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Manufacturing Patients IT Hospital 98

FDA Law Blog

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.

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Manufacturing Utilities Provider IT 59

FDA Law Blog

SEPTEMBER 28, 2022

Valley Hospital, Inc. Jones] acted with actual malice or with wanton and willful disregard of” the plaintiff’s health and, in fact, there was evidence he informed the patient of the procedure’s risks. by obtaining appropriate informed consent). By Steven J. Gonzalez & Jeffrey N. LEXIS 679 (NJ Aug.

Provider 59

Provider Hospital Patients Manufacturing 59

FDA Law Blog

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 Blog

NOVEMBER 22, 2022

Some of us might still recall the 2017 salmonella outbreak linked to raw turkey products that caused over 279 infections, 107 hospitalizations, and one reported death in 41 states. What information firms must maintain and share under the rule depends on the type of activities they perform in the supply chain with respect to an FTL food.

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Supply Chain Illness Family Families 52

FDA Law Blog

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. Emphasis added.)

Medical 53

Medical Diagnosis Healthcare Clinic 53

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

GeriPal

MAY 8, 2025

Vincent’s Hospital in Melbourne, Australia. Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? We dedicated team working with cancer and palliative medicine in our hospital. James, welcome to the GeriPal Podcast.

Illness 107

Illness IT Patient-Centered Patients 107

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

GeriPal

DECEMBER 7, 2023

And so we do see hospital admissions for heat exposure and certainly cardiovascular and respiratory problems related to air pollution with climate change and also cognitive problems. And actually, we worked with a hospital on a project like that to demonstrate we don’t need to wear gloves for every time we touch a patient.

Healthcare 129

Healthcare IT Education Community 129

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 7-8; NPRM at 44,614.

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Physicals Medical Clinic Emergency Room 69

GeriPal

OCTOBER 31, 2024

But it feels the same in that I was on call a lot over the summer, and I took care of a lot of people behind those hospital walls. And we don’t see hospitals being strained as much anymore. You know, of course, serious disease, hospitalization and death. And, you know, some people are still getting very sick.

Vaccination 127

Vaccination IT Patient-Centered Patients 127

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 59

Medical Manufacturing Patient-Centered Provider 59

Physicians News Digest

APRIL 2, 2025

By Julie Appleby Tim Winard knew he needed to buy health insurance when he left his management job in manufacturing to launch his own business. Early last year, he had the colonoscopy at a hospital in Elmhurst, Illinois, not far from his home in Addison. Winard said the hospital declined the offer. Then the bill came.

Insurance 52

Insurance Screening Hospital Patient-Centered 52

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 98

Manufacturing Supply Chain Patient-Centered Utilities 98