FDA Law Blog

MAY 3, 2021

The implementing regulations provide an alternative option for delayed submission of results information if the responsible party submits a certification that a premarket submission “has been filed or will be filed within 1 year” of the reporting deadline. By McKenzie E. Cato & Michelle L. The notice was given to Acceleron Pharma, Inc.,

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CDOCS

MARCH 15, 2021

important;" xml:lang="EN-US">In 2007, a few of us were sitting at dinner when the CEO of our company at the time, Mr. Imtiaz Manji, came up with an idea for the cerecdoctors.com Magazine. Our goal is to provide the same engaging, informative, and educational content, only in a digital manner.

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Family Families Education Community 52

The Health Policy Exchange

MAY 20, 2013

Unfortunately, recent case studies have illustrated that FDA approval does not necessarily provide assurances of effectiveness and safety. Although a 2007 meta-analysis first sounded the alarm about rosiglitazone's cardiovascular risks, the manufacturer successfully stalled regulatory action in the U.S.

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CDOCS

MARCH 26, 2021

png]<br /> <em><span style="font-size:11px;">​Figure& 1:& <span data-contrast="auto" xml:lang="EN-US">A life-long bruxer, this patient presented with lost teeth in the posterior and compensatory eruption of lower anterior teeth.</span>& png] [image:12.png]<br

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Family Families Patients Provider 52

GeriPal

FEBRUARY 15, 2024

The insight started when Carmen, an orthopedic surgeon-researcher, and Katie, a physical therapist- researcher participated in ride-alongs with EMS providers to patient’s homes. And yet, after assisting the older adult to their feet, the EMS providers would leave. Going into patient’s homes was eye opening. Their job was done.

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Community Transportation IT PCP 116

The Clinical Problem Solvers

FEBRUARY 8, 2023

Between 2007 – 2019, Black individuals experienced a higher death rate for opioid overdose deaths than any other racial or ethnic group. A more Western perspective on health care emphasizes the role of physicians and health care providers and marginalizes the role and contributions of doulas and midwives.

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Community Patient-Centered Mental Health Board-Certified 52

GeriPal

FEBRUARY 29, 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. Lynn: Okay.

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IT Patient-Centered Illness Education 127

GeriPal

NOVEMBER 2, 2023

I’ve seen this question come up a lot since finishing fellowship nearly two decades ago. Historically, answers generally lamented the ever increasing need for geriatrics without a corresponding growth in the number of specialists in the field. Mike, welcome to GeriPal. Mike: Great to be here. Alex: We’ll take any Warriors we can get.

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Board-Certified IT Community Medical Student 91

FDA Law Blog

MAY 11, 2023

Instead, the Government takes the position that, to support an inference of intent to induce infringement, independent evidence that the generic sponsor understood its carved-out labeling to encompass patented uses and proof that petitioner expected and encouraged doctors to rely on the labeling should be necessary.

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GeriPal

FEBRUARY 17, 2022

This tool provides a clinical recommendation for starting/stopping medications and cancer screening based on the prognosis of the patient in front of you. Think of the 10 years it takes to benefit from colon or breast cancer screening, which is designed to detect slow growing cancers. See screenshot below. James: Thanks for having me.

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Clinic IT Patients Medical 68

GeriPal

SEPTEMBER 12, 2024

Well-being committees are popping up at every level of an organization. And C-suites now have chief wellness officers sitting at the table. Eric 01:54 Why’d you pick this song, Naomi? Naomi 01:57 Because it really talks about this beautiful experience of our beloved, which is ourselves, the part that we often cut out of the equation.

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IT Healthcare Healthcare Professional Patient-Centered 112

GeriPal

AUGUST 11, 2022

Myself personally, I was in PCEP at Harvard, I think like 2007 or something with Rachelle Bernacki and a bunch of other great people. Alex: Today, we are truly honored to welcome Susan Block, who is the founder of the department of psychosocial oncology at the Dana-Farber Cancer Institute in the Brigham and Women’s Hospital in Boston.

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Illness IT Family Families 110

GeriPal

APRIL 10, 2025

Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it. I went into emergency medicine to act. I cant do the primary thing Ive been trained to do: ABC, ABC, ABCs. They got training in Vital Talk and ELNEC. They got feedback. So did it matter?

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Patient-Centered IT Hospital Patients 78

GeriPal

JUNE 30, 2022

Eric: So we’re going to be talking about dementia and considerations around surgery for individuals with dementia. Before we go into this topic, who has a song request for Alex? It was Remember Me. Was that the title? Alex: I think it’s I Will Remember You. Joel: Yeah, right, I Will Remember You, right. Alex: … Sarah McLachlan.

Patient-Centered 101

Patient-Centered Complication Patients IT 101

FDA Law Blog

JULY 11, 2021

DEA previously authorized MNTPs to dispense remotely on an ad hoc basis, and placed a moratorium on new authorizations in 2007. NTPs must also provide local and state licensing and registration information to DEA investigators during inspections and prior to transporting controlled substances. By Larry K.

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Transportation Patient-Centered Medical Patients 52

FDA Law Blog

SEPTEMBER 6, 2021

Though the carve-out seems at odds with FDA’s regulations requiring generic drugs to have the “same labeling” as their RLDs, such regulations specifically provide for differences arising from carved-out, patent-protected method of use. Teva received tentative approval in June 2003 and launched in 2007 after a blocking patent expired.

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IT Provider ER Insurance 52

FDA Law Blog

AUGUST 21, 2023

Recall that the funds provided under the Prescription Drug User Fee Acts (PDUFA) are not available to support the agency’s efforts related to monograph drugs.) (Recall that the funds provided under the Prescription Drug User Fee Acts (PDUFA) are not available to support the agency’s efforts related to monograph drugs.)

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Manufacturing Consulting Healthcare Professional Vaccination 40

FDA Law Blog

MAY 26, 2025

Specifically, these are procedures and drugs used in providing what HHS had, until recently, referred to as gender-affirming care. Department of Health & Human Services purporting to provide a comprehensive review of the evidence and best practices for promoting the health of children and adolescents with gender dysphoria.

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Manufacturing Provider Medical IT 59