FDA Law

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Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway.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

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. These legislative changes helped.

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FDA Law

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

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. FDA-2022-E-3124 ).

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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. What about topical anesthetics? 95% confidence interval = 1.01-3.93;

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FDA Law

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

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. It harkens to the paternalism in medicine of the past.

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FDA Law

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. leave you scratching your head (we’ll call it “Who’s Buried in Grant’s Tomb?”). 351, 355-56 (1985). l 56(c)(4) and 37 C.F.R.

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GeriPal

MARCH 2, 2023

By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. One thing is clear, it is not because people are using it for FDA approved indications. The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia.

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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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FDA Law

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. This has been a decision we’ve been closely following. First, it was noteworthy what was missing from the label.

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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. Who do we have on with us today? Alex: End-of-life doulas. Jane, welcome to the GeriPal podcast. Jane: Thank you for having me. John: I do. It was on his last album.

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FDA Law

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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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

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

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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PEMBlog

JUNE 5, 2024

2012 Jan 13;61(RR-1):1-20. Cervical Spine Injuries are fortunately rare in children. this episode is all about learning when to suspect them, how to immobilize the C-spine properly, and which imaging test to choose. Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011.

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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. In a few days, he would drive from Mississippi to Washington, D.C.,

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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. And Ken Covinsky, avid baseball fanatic, joins us and notes that the day we record (April 15) is Jackie Robinson day. It is a terrific book.

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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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