The Clinical Problem Solvers

APRIL 24, 2025

Simon is a pediatric addiction medicine psychiatrist at Boston Children’s Hospital; an assistant professor in psychiatry at Harvard Medical School; a recent Commonwealth Fund fellow in health policy at Harvard University; and the medical director of Wayside Youth & Family Support Network.  JAMA Netw Open. 2020;3(8):e2013100.

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FDA Law Blog

MAY 19, 2025

For a controlled substance prescription to be effective, that is valid, it must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of their professional practice. Complaint, 82. 81, 86, 251. 81, 89, 251.

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FDA Law Blog

JUNE 29, 2022

Breakthrough Therapy Designation (BTD) was created in 2012 as part of the FDA Safety & Innovation Act (FDASIA). Subsequently, CDER, in MAPP 6025.6 , and CBER, in SOPP 8212 , provided more granularity as to how this process would work with step-by-step instructions for FDA staff.

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FDA Law Blog

AUGUST 18, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. The De Novo process provides a regulatory pathway to classify novel devices for which general controls alone or general and special controls provide reasonable assurance of safety and effectiveness for the intended use.

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FDA Law Blog

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. FDAs interpretation of several threshold criteria for eligibility (serious condition, available therapy, unmet medical need) will continue to rely upon the 2014 Guidance.

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FDA Law Blog

MARCH 4, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. Since the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012, manufacturers have been required to notify FDA of product changes affecting certain finished drugs and biological products.

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FDA Law Blog

FEBRUARY 29, 2024

As FDA explains on its website (which includes lists— here and here —of the more than 300 Accelerated Approvals (and withdrawals)): The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint.

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PEMBlog

MAY 11, 2023

And what about the J-Tip, a device that uses pressurized gas to send medication into the subcutaneous portion of the skin – deeper than topical anesthetics? Neither HR nor NCFS differed, and perception of pain by provider, and need for additional lidocaine were similar. 2012 Jul;28(7):687-90. 95% confidence interval = 1.01-3.93;

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FDA Law Blog

JUNE 23, 2021

In 2012 we at the Agency, under Dr. Janet Woodcock’s leadership, identified the need for more systematic patient engagement — a way to improve representativeness and be more proactive rather than reactive to interacting with patient communities. However, the scope of patient input goes beyond setting the clinical context.

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FDA Law Blog

JUNE 14, 2022

Though Esai’s Fycompa was initially approved in October 2012, it wasn’t scheduled until January 2014, meaning that Esai lost a little more than a year of patent life awaiting scheduling—in addition to the time spent in regulatory development and review.

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FDA Law Blog

FEBRUARY 27, 2024

For years after the enactment of the Hatch-Waxman Amendments the PTO interpreted the PTE statute to permit multiple PTEs, provided there are separate, but not necessarily different, regulatory review periods. See Lourie, Patent Term Restoration: History, Summary, and Appraisal, 40 Food, Drug, and Cosm. 351, 355-56 (1985).

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PEMBlog

JUNE 2, 2025

Before your blood pressure rises as well, know that this PEMBlog article is here to provide an overview of the recognition and management of hypertensive emergencies. 3 mg/kg/hr; onset of action is less than 5 minutes, and the duration of medication lasts between 2-6 hours. Labetalol dosing: 0.2-1

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GeriPal

MARCH 2, 2023

Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? It’s not a controlled substance medication. Eric: So I heard gabapentin is the 10th most commonly prescribed medication in the US. Eric: Are these generic? Nisha: Both of them are generic, yeah.

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GeriPal

MARCH 7, 2024

We are delighted to welcome Jane Euler, who is lead doula and co-founder of Present for You, which is a benefit LLC company that provides doula support at the end-of-life. We are doulas for those with serious illness and those at end-of-life, just a longitudinal relationship, nonmedical support to provide presence. Jane: Right.

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FDA Law Blog

JUNE 7, 2021

It is noteworthy that this sentence that no clinical benefit has been established was deemed by FDA as unnecessary for Aduhelm to provide additional context beyond that the approval is based on reduction in amyloid beta plaques. be “reasonably likely to predict” ultimate clinical benefit).

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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. In Section I.A,

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PEMBlog

APRIL 26, 2023

Pediatrics November 2012; 130 (5): e1416–e1423. 2012-2481 Haasz, M., I’m Dr. Carney and I am a pediatric resident at Cincinnati Children’s Hospital Medical Center. In our current environment, it can feel overwhelming as a healthcare provider to discuss firearms. Melzer-Lange, Joseph O’Neil, Wendy J. Powell, Seth J.

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GeriPal

MARCH 20, 2025

Summary Transcript CME Summary Eric and Alex have featured discussions about complex bioethical concepts around caring for people at the end of life, including voluntarily stopping eating and drinking ( VSED ), and multiple episodes about the ethical issues surrounding medical aid in dying ( MAID ). Alex 00:14 We have a very full house today.

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PEMBlog

JUNE 5, 2024

2012 Jan 13;61(RR-1):1-20. So the highest risk patients, these patients have a risk of cervical spine injury of about 12%, are going to recommend immediate medical attention. I’ve provided a link in the show notes. MMWR Recomm Rep. PMID: 22237112. and somebody with a focal neurological deficit.

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GeriPal

FEBRUARY 2, 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.

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GeriPal

AUGUST 1, 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.

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Physician's Weekly

JUNE 25, 2025

Dangerous changes loomed: To compensate for tax cuts for the wealthy, Trump’s “big, beautiful” bill and budget proposal for fiscal year 2026 threaten to curtail Medicaid, which provides health coverage for people with low incomes and disabilities. About 40% of adults with HIV rely on it for their lifesaving treatments.

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GeriPal

APRIL 17, 2025

Farah provides clear examples from the Biden administration, in which having the most diverse cabinet in history was critical to building bridges, empathy, and inspiring others to feel included. You know, I’m thinking about, like, you know, I think, Eric, you served on our medical school admissions committee once.

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Physicians News Digest

APRIL 3, 2025

Survey data gathered by AHRQ provides much of what is known about hospitalizations for motor accidents, measles, methamphetamine, and thousands of other medical issues. Medical errors caused by missed diagnoses, drug errors, hospital infections, and other factors kill and maim tens of thousands of Americans each year.

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