FDA Law Blog

JUNE 23, 2021

Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. By James E.

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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Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway.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 application and use of accelerated approval has evolved dramatically since it was first developed by the Agency to help address the HIV/AIDS epidemic in the late 1980s.

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FDA Law Blog

AUGUST 18, 2024

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. calendar years is both inexplicable and deprives patients and clinicians of options.

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FDA Law Blog

FEBRUARY 29, 2024

If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. FDA-2022-E-3124 ).

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PEMBlog

MAY 11, 2023

Some general recommendations to reduce pain during LP include: Comfortable Positioning: The patient should be instructed to lie on their side with their knees drawn up to their chest and their chin tucked in, or sit upright with their head and upper back forward (often on a bedside table with a pillow). Is there evidence for the J-Tip?

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FDA Law Blog

MARCH 1, 2023

In this report, it’s stated that 62% of drug shortages reported between 2012 and 2017 were due to quality issues which is attributed in part to a lack of recognition or reward for manufacturers with mature quality management systems that focus on continuous improvement and early detection of supply chain issues. By Holly N.

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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. leave you scratching your head (we’ll call it “Who’s Buried in Grant’s Tomb?”). 351, 355-56 (1985).

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FDA Law Blog

APRIL 30, 2023

112-144 (2012). Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. That bill is S. 110-85 (2007), as amended by Section 301 of Pub. Yeah, you read that correctly!

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Common Sense Family Doctor

FEBRUARY 1, 2025

Since the turn of the century, the rise of hospitalists and the corresponding decline in the number of office-based family physicians who provide inpatient care for their own patients has magnified the value of optimizing the handoff from hospital-based teams to primary care physicians.

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FDA Law Blog

MARCH 13, 2023

Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). After holding a series of these meetings, FDA realized that PFDD meetings were extremely successful and wanted the process to continue.

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GeriPal

MARCH 2, 2023

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. There are a lot of reasons that may explain the massive increase in use of these drugs.

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PEMBlog

JUNE 2, 2025

Upon entering the room, you find the patients nurse at the bedside already in mid-conversation with the patients parent. 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.

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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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GeriPal

FEBRUARY 2, 2024

First, in our editorial, we expressed concern about the length of stay metric not being patient centric, though important for health systems focused on cost savings. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Much more to come.

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PEMBlog

DECEMBER 14, 2023

2012 Oct;147(4):619-26. Tracheomalacia and bronchomalacia in children: incidence and patient characteristics. Laryngomalacia, is the most common cause of infant stridor. Early diagnosis is crucial as it can impact a child’s growth and development. Available from: [link] Hartl TT, Chadha NK. Otolaryngol Head Neck Surg.

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PEMBlog

JUNE 5, 2024

Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011. 2012 Jan 13;61(RR-1):1-20. The most common injuries seen in these younger patients are growth plate fractures and ligamentous injuries. Cervical Spine Injuries are fortunately rare in children. MMWR Recomm Rep.

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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

Kit Carney and Dr. Kristen Humphrey discuss gun violence, its impact on our patients and their families, as well as practical tips on advocating for safe storage of firearms, and how we can support victims of violence. Pediatrics November 2012; 130 (5): e1416–e1423. 2012-2481 Haasz, M., Melzer-Lange, Joseph O’Neil, Wendy J.

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GeriPal

MARCH 20, 2025

Recently, discussion has emerged about how these issues intertwine in caring for patients with advancing dementia who have stated that they would not want to continue living in that condition: for those with an advanced directive to stop eating and drinking, how do we balance caring for their rational past self and their experiential current self?

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FDA Law Blog

JANUARY 11, 2022

Amarin also sued Health Net, an insurer that provides coverage for both Vascepa and Hikma’s generic. Specifically, Amarin alleged that Hikma’s label “teaches CV risk reduction” due to “a notice regarding side effects for patients with CV disease” and an absence of a statement that the generic “should not be used for the CV indication….”

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FDA Law Blog

JANUARY 11, 2022

Amarin also sued Health Net, an insurer that provides coverage for both Vascepa and Hikma’s generic. Specifically, Amarin alleged that Hikma’s label “teaches CV risk reduction” due to “a notice regarding side effects for patients with CV disease” and an absence of a statement that the generic “should not be used for the CV indication….”

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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 11, 2025

And that support is for the patient and their caregiver — because both can experience social isolation and distress after a diagnosis. A 2021 study published in Frontiers in Public Health indicated that even online memory cafes during the pandemic provided social support for both patients and their family members.

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GeriPal

APRIL 17, 2025

Summary Transcript CME Summary I read Farah Stockmans article in the NYT on why attacks on DEI will cost us all , and thought, Yes, and everyone includes harm to our healthcare workforce, our patients, and their families. And Ken Covinsky, avid baseball fanatic, joins us and notes that the day we record (April 15) is Jackie Robinson day.

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Physicians News Digest

APRIL 3, 2025

The episodes turned both women into advocates for patients and spurred research that made American health care safer. Haskell, of Columbia, South Carolina, has done research and helped write AHRQ-published surveys and guidebooks on patient engagement for hospitals. It also has published tools and guidelines to enhance patient safety.

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