FDA Law

SEPTEMBER 21, 2022

The monkeypox test policy describes how FDA will prioritize review of EUA requests for monkeypox tests, stating that FDA intends to focus on requests for high-throughput tests, tests with home specimen collection, or rapid diagnostic tests, all from experienced developers with high manufacturing capacity.

Manufacturing 52

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

Patient-Centered 52

Patient-Centered Healthcare Manufacturing Provider 52

FDA Law

JANUARY 26, 2022

FDA alleged that because the TV ads contained representations or suggestions relating to Emgality’s indication for use, they were required to include risk information as well adequate provision for the dissemination of the PI or a brief summary as required by 21 C.F.R.

IT 40

IT Education Utilities Patient-Centered 40

Alabama Academy of Family Physicians

FEBRUARY 19, 2025

The bill also requires the Alabama Statewide Area Health Education Center Program Office to administer and verify the eligibility of physicians claiming the credit and mandates an evaluation of the program’s success during the 2030 fiscal year. The bill also addresses parental access to health information and parental rights.

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Insurance Management Hospital Vaccination 130

Physician's Weekly

JUNE 19, 2025

His work also appears on All Things Considered, Marketplace, the BBC, 99 Percent Invisible, and Reveal, from the Center for Investigative Reporting. This is the kind of information we all need, all deserve. This is a, you know, board certified pediatric neurologist who’s been seeing this patient for years. It was denied.’

Insurance 52

Insurance IT Board-Certified Medical 52

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 107

Illness IT Patient-Centered Patients 107

FDA Law

JUNE 14, 2023

He highlighted the following key features of TAP: An Innovative Approach To provide proactive support and guidance to medical device manufacturers, FDA has introduced a new CDRH position known as the “TAP Advisor.” Also, it is unclear which office within CDRH appoints the TAP Advisor, e.g., center-level, OPEQ-level, or division-level.

Manufacturing 45

Manufacturing Medical Patient-Centered Appointment 45

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. I think Bob also noted documenting it.

Illness 72

Illness IT Healthcare Patient-Centered 72

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

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 18; NPRM at 44,605.

Physicals 69

Physicals Medical Clinic Emergency Room 69

GeriPal

DECEMBER 7, 2023

Alex: And we’re delighted to welcome Ruth McDermott-Levy, who is Professor in the College of Nursing at Villanova University and Co-Director of the Mid-Atlantic Center for Children’s Health and the Environment. And that’s a good thing to share with an older patient or client that making decisions about your activity.

Healthcare 129

Healthcare IT Education Community 129

GeriPal

OCTOBER 31, 2024

And the reason why I’m choosing is because it’s respiratory virus season and we don’t want our patients to catch their breath. That trauma may have been caring for patients who were sicker from respiratory virus than I often have ever seen. Let’s say for nursing home patients, older. All good ones.

Vaccination 127

Vaccination IT Patient-Centered Patients 127

FDA Law

FEBRUARY 20, 2025

Interestingly, counsel focused his arguments exclusively on parrying legal attacks, rather than arguing why the rule was necessary to protect patients. These firings will stretch the Centers resources to take on its existing workload, let alone handle thousands of complex and innovative LDTs.

Patient-Centered 102

Patient-Centered Consulting Government Clinic 102

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

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. The fact that short-term plans can cover fewer services, conditions, and patients is why they are generally less expensive than an unsubsidized ACA plan. Capitol, and at the White House.

Insurance 52

Insurance Screening Hospital Patient-Centered 52

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