FDA Law

NOVEMBER 29, 2023

Guiding Principle 10 focused on monitoring the performance of the models and managing re-training risks. Five guiding principles were identified for PCCPs and relate to being focused, risk-based, evidence-based, transparent, and taking into consideration total product lifecycle management.

Management 115

Management Manufacturing Medical Healthcare 115

FDA Law

APRIL 25, 2023

Shapiro — Does your firm manufacture a “cyber device”? Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.” Software as a Medical Device, or SaMD) or the software is embedded in a traditional hardware device (i.e.,

Specialization 105

Specialization Provider Medical Manufacturing 105

FDA Law

NOVEMBER 20, 2024

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device.

Provider 59

Provider Medical Manufacturing Consulting 59

FDA Law

SEPTEMBER 22, 2024

Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026. SCF : LDT, unmet need within an integrated healthcare system.

Manufacturing 64

Manufacturing Electronics Provider Management 64

FDA Law

NOVEMBER 16, 2021

Baumhardt , MS, MJ, MT(ASCP), RAC, FRAPS, has joined the firm as a Senior Medical Device Regulation Expert, and that Sophia Gaulkin has joined the firm as an Associate. Baumhardt provides counsel to medical device, in vitro diagnostic, and combination product manufacturers on a wide range of pre- and post-marketing regulatory topics.

Medical 40

Medical Healthcare Manufacturing Management 40

Physician's Practice

JUNE 9, 2025

a health care attorney with Roetzel & Andress, joins the show to explore the legal risks of prescribing GLP-1 medications. Financial Relationships with Pharmaceutical Companies (00:20:10)** Legal and ethical concerns for physicians with financial ties to GLP-1 drug manufacturers, including anti-kickback laws. Adler, J.D.,

Management 52

Management Telemedicine Insurance Patients 52

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 120

IT Patient-Centered Patients Clinic 120

FDA Law

JANUARY 5, 2025

In response to the proposed rule, approximately 200 comments were submitted to the docket, and a meeting took place among FDA, the White House Office of Management and Budget (OMB) and the Consumer Healthcare Products Association (CHPA). The third was the postmarketing requirement for reporting an ACNU failure.

Provider 59

Provider Healthcare Individual Manufacturing 59

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 Manufacturing Insurance Provider 40

FDA Law

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. We find that this information is noteworthy for manufacturers to consider.

Manufacturing 45

Manufacturing Engineering Clinic Provider 45

Alabama Academy of Family Physicians

FEBRUARY 19, 2025

As the 2025 legislative session swings into full gear, the Alabama Academy of Family Physicians (AAFP) has set its sights on a cadre of pivotal bills set to shape the healthcare landscape for years to come. Chip Brown, HB 2 proposes a change to existing law regarding the consent process for medical procedures involving minors.

Insurance 130

Insurance Management Hospital Vaccination 130

GeriPal

MARCH 2, 2023

2022 Perioperative Gabapentin Use in Older AdultsRevisiting Multimodal Pain Management JAMA IM. It’s not a controlled substance medication. Eric: So I heard gabapentin is the 10th most commonly prescribed medication in the US. J Am Geriatr Soc. Eric: Are these generic? Nisha: Both of them are generic, yeah.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

FDA Law

OCTOBER 17, 2023

Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities and to certain non-addictive medical products to treat pain or addiction. By Philip Won & Lisa M.

Medical 53

Medical Diagnosis Healthcare Clinic 53

FDA Law

MAY 5, 2024

The White House Office of Management and Budget will review the rescheduling proposal. Democratic state attorneys general viewed rescheduling “as a public safety imperative” and also encouraged rescheduling to schedule III based on FDA’s “scientific and medical conclusions.” and lack accepted safety for use under medical supervision.

Medical 95

Medical Manufacturing Physicals Healthcare Professional 95

FDA Law

JUNE 14, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “Total Product Life Cycle Advisory Program or TAP pilot — the most exciting thing in MDUFA V. Review teams already appoint a lead reviewer to each submission and sometimes assign a project manager to an extensive project.

Manufacturing 45

Manufacturing Medical Appointment Patient-Centered 45

GeriPal

MAY 8, 2025

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? And those of us who work in palliative care are more familiar with the 5ht3 receptor, which we use for nausea management. So medication adjustments. So 5ht2 was.

Illness 107

Illness IT Patient-Centered Patients 107

GeriPal

DECEMBER 7, 2023

So our elders who are people of color, people who live in places that are already challenged by poor air quality and those things and access to healthcare, they also have greater risks. So the things that Karl mentioned, but also access to healthcare during a disaster or even heat. Why is it up to the healthcare system?

Healthcare 129

Healthcare IT Education Community 129

FDA Law

SEPTEMBER 8, 2022

As it stands, the rule allows insurers and pharmacy benefit managers (PBMs) to broadly use copay accumulator programs, which have long been criticized by patient advocacy groups as padding insurers’ pockets while leaving patients high and dry. These prohibitions are often referred to as copay accumulator adjustment programs.

Insurance 83

Insurance Patients Manufacturing Patient-Centered 83