FDA Law Blog

JUNE 29, 2022

The Expedited Programs Guidance describes situations warranting rescission as when emerging data no longer support the BTD, another product gains traditional approval and evidence is not provided that the designated drug may demonstrate substantial approval over the approved product, or when the program is no longer being pursued.

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FDA Law Blog

JULY 5, 2023

As a reminder, in Title I of the 2013 Drug Quality and Security Act (DQSA) (the Compounding Quality Act), Congress created the “outsourcing facility” FDA registration category, and set forth statutory parameters for their operation in new section 503B of the FDCA. Draft Guidance III.B.2(e) Draft Guidance III.B.2(d) Draft Guidance III.B.1.

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GeriPal

JANUARY 12, 2023

Not every hospital or every health system is the same physically or financial incentives or which clinical programs exist and patient demographics. JAMA IM 2013, you had a paper that showed what, 300, $400. And so how can we adopt these five elements for the unique environment that we’re in?

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FDA Law Blog

APRIL 30, 2021

Despite FDA’s historical policy of not ruling on ANDA suitability petitions within the statutory deadline, leading to a loss of faith in the process itself, FDA, in August 2013, published a Manual of Policies and Procedures (“MaPP”) – FDA, Manual of Policies and Procedures, Office of Generic Drugs: ANDA Suitability Petitions, MaPP 5240.5 (Aug.

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FDA Law Blog

APRIL 30, 2021

Despite FDA’s historical policy of not ruling on ANDA suitability petitions within the statutory deadline, leading to a loss of faith in the process itself, FDA, in August 2013, published a Manual of Policies and Procedures (“MaPP”) – FDA, Manual of Policies and Procedures, Office of Generic Drugs: ANDA Suitability Petitions, MaPP 5240.5 (Aug.

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PEMBlog

OCTOBER 2, 2024

I’ll dive into the latest clinical practice guidelines and discuss evidence-based approaches to diagnosis and treatment. Understanding dyspepsia and its clinical presentation. Join me as I scope out the nuances of gastroesophageal reflux and gastritis and provide practical insights for clinicians in the emergency setting.

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The Health Policy Exchange

SEPTEMBER 16, 2013

Supporters of evidence-based preventive medicine cheered when the Affordable Care Act required Medicare and private health insurers to provide first-dollar coverage for all preventive services assigned an "A" or "B" recommendation grade by the U.S. Preventive Services Task Force.

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The Clinical Problem Solvers

MARCH 4, 2024

42:00 Abolitionist reimaginings of Health 55:05 Democratizing Narrative Medicine 1:03:05 Closing Remarks and Clinical Pearls Speaker biographies (Abbreviated) Zahra Khan is an educator and editor whose work emerges at the intersection of narrative, healing and disability justice, and liberation pedagogy.

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ABIM

JUNE 4, 2025

Representatives from the American Association of Clinical Endocrinology (AACE), the Association of Program Directors in Endocrinology, Diabetes and Metabolism (APDEM) and the Endocrine Society joined for a portion of the meeting*.

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GeriPal

SEPTEMBER 1, 2022

In day-to-day practice, It’s hard to imagine providing excellent hospice or palliative care services without access to a team social worker. Barbara: Oh, I think it was 2013. Now, my SWHPN friends will get mad at me if I got that wrong, but I think it was 2013. I can figure out how to provide care in this way.

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ABIM

JUNE 24, 2025

The questionnaire gathers information about clinical work and practice patterns, and ABIM uses the information to help update exam blueprints, develop policies for initial certification and MOC, and ensure adequately diverse representation of the profession in research. ASH has engaged in lobbying efforts in Washington, D.C.

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ABIM

JUNE 11, 2025

Some members of the Specialty Board were interested in the LKA experience, participant survey results—particularly responses about fairness—and how LKA performance data might reflect on clinical outcomes. ABIM’s website features expansive sections on research related to assessment and clinical outcomes.

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ABIM

MAY 30, 2025

The questionnaire gathers information about clinical work and practice patterns, and ABIM uses the information to inform operations, such as updating exam blueprints, developing policies for initial certification and MOC, and ensuring adequately diverse representation of the profession in research and governance.

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GeriPal

JUNE 19, 2025

This is like, back in 2013, and I joined the faculty at the Icahn School of Medicine at Mount Sinai. So when I joined Sinai In 2013, I was in a different form at that time. Knowing that the community is really underrepresented in sort of our knowledge, what we do, how we provide care that’s truly inclusive and welcoming.

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FDA Law Blog

OCTOBER 24, 2024

Mutations in these genes vastly increase the risk of breast and ovarian cancer in women who carry them, and the isolation of BRCA 1/2 allowed clinical laboratories to develop tests enabling the identification of women at heightened risk. HPM is currently representing AMP in unrelated litigation.)

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FDA Law Blog

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA). This guidance was finalized in 2020.

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FDA Law Blog

APRIL 8, 2024

MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. Unfortunately, the White Paper does not provide further analysis on the generic sterile injectables and instead refers back to FDA’s analysis from 2013-2017.

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GeriPal

NOVEMBER 2, 2023

So a couple weeks after it was published, I took a trip to a medical school in the western part of the country and I was visiting to think about their geriatrics research program, and they had a geriatrics evaluation clinic. And I met with the clinical pharmacist who worked in that clinic and she told me, “You know what?

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PEMBlog

JUNE 5, 2024

It was inspired by a hot-off-the-presses publication from the Pediatric Emergency Care Applied Research Network (PECARN) focused on clinical decision rules for cervical spine imaging in children. If they have no pain in the midline with any of these movements, then the cervical spine is clinically cleared. Harding, M., Leonard, J.

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GeriPal

MARCH 3, 2022

I am wondering whether it’s the conversations and preparation that’s primary care providers and outpatient providers are having with a lot of these patients and families to either prevent an ICU admission or potentially address their goals, such that they don’t go into the ICU. How do I reconcile these two issues?

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The Clinical Problem Solvers

MARCH 31, 2021

The COVID-19 pandemic provides a similar opportunity today for us to scale up our critical consciousness and re-examine the functioning of our society. The Clinical Problem Solvers Podcast. People are naming racism, settler colonialism, and imperialism more than ever. Kleinman, A., & Basilico, M. April 1, 2021.

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The Clinical Problem Solvers

MAY 2, 2023

[link] CPSolvers: Antiracism in Medicine Series Episode 21 – Psychosocial and Cultural Considerations for Providing Healthcare to Immigrant and Refugee Populations Show Notes by Kiersten T. This discussion is hosted by Sudarshan Krishnamurthy, Ashley Cooper, and LaShyra Nolen.

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PEMBlog

MAY 9, 2024

Well, they say that LP should be performed when there are meningeal signs or symptoms or other clinical features that suggest possible meningitis or intracranial infection. And the clinical clues that a seizure has ended are often subtle. You’re providing education and reassurance to a worried family. You can do this.

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