FDA Law Blog

AUGUST 10, 2023

Section 704(a)(4) was added to the FDCA by the Food and Drug Administration Safety and Innovation Action (FDASIA) in July 2012. Despite FDA having the authority to conduct paper inspections since the statutory provision was added to the FDCA by FDASIA in 2012, FDA did not issue a warning letter citing Section 704(a)(4) until January 2021.

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FDA Law Blog

JULY 7, 2022

In March 2012 , FDA convened a public meeting to discuss a new paradigm under consideration, “Using Innovative Technologies and Other Conditions of Safe Use to Expand Which Products Can Be Considered Nonprescription”. Among other things, the applicant would need to include a statement of the necessity of the ACNU.

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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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PEMBlog

MAY 1, 2025

Learning Objectives Describe the classic and atypical clinical presentations of Parvovirus B19 infection in pediatric patients, including erythema infectiosum, arthropathy, transient aplastic crisis, and chronic anemia in immunocompromised hosts. So as you can see, this virus does a lot of stuff. But what is it? Well, let’s get nerdy.

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Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway.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

MARCH 4, 2024

The draft guidance provides recommendations for applicants and manufacturers about the requirements for notifications about production changes of certain finished drugs and biological products and certain active pharmaceutical ingredients (API), and outlines information FDA would like to receive in addition to the requirements.

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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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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. This amendment allowed sponsors with low or moderate risk devices to proactively employ the De Novo process.

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FDA Law Blog

APRIL 16, 2024

In 2020, CMS issued a final rule providing a broad definition of “new formulation” as “any change to the drug, provided that the new formulation contains at least one active ingredient in common with the initial brand name listed drug.” We wrote a memorandum summarizing CMS’ regulation here.

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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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PEMBlog

MAY 11, 2023

Secondary outcomes included changes in heart rate (HR) and NFCS throughout the procedure, difficulty with LP, number of LP attempts, provider impression of pain control, additional use of lidocaine, skin changes at LP site, and LP success. This helps to open up the spaces between the vertebrae and makes it easier for the needle to enter.

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FDA Law Blog

APRIL 3, 2023

Over ten years after this statutory amendment, on December 31, 2020, CMS finalized a broad definition of “new formulation” as “any change to the drug, provided that the new formulation contains at least one active ingredient in common with the initial brand name listed drug.” NDA or BLA) drugs.

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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

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 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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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). l 56(c)(4) and 37 C.F.R.

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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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Annals of Family Medicine

NOVEMBER 20, 2024

The time horizon was anchored in January 2012: pre-pandemic period was defined as January 2012 to March 2020, and the pandemic period as April 2020 to June 2022. Outcome Measures: The monthly prevalence was calculated as the percent of mental health visits (MHV) among all visits to a provider in that month.

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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. 2012 Sep 5;4:85-92. Nicardipine dosing: bolus at 30 mcg/kg/bolus (maximum 2 mg/dose), then a continuous drip at 0.5-4 Quick References 2024; 10.1542/aap.ppcqr.396258.

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

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FDA Law Blog

MARCH 13, 2023

The FDA took an early lead in the evolution of this movement when they launched the Patient Focused Drug Development (PFDD) initiative in 2012. Rather than speaking with one or two people with a condition of interest as had been previously done, they sought to find a more systematic way of getting broad patient and caregiver feedback.

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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

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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PEMBlog

DECEMBER 14, 2023

2012 Oct;147(4):619-26. Laryngomalacia, is the most common cause of infant stridor. Early diagnosis is crucial as it can impact a child’s growth and development. Most infants get better on their own, but those with severe symptoms need surgical interventions like supraglottoplasty. Treasure Island (FL): StatPearls Publishing; 2023 Jan-.

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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., In our current environment, it can feel overwhelming as a healthcare provider to discuss firearms. Healthcare providers need to be aware of and manage their biases concerning this topic, and that starts by ensuring that we ask all families about it.

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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

MARCH 20, 2025

And is there a middle path to provide some degree of comfort while also hastening the end of life? Should these patients qualify for medical aid in dying medications? Eric 00:13 And Alex, who do you have with us today? Alex 00:14 We have a very full house today. Hope Wechkin brought this topic to us. We love it when our guests suggest things.

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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. Hikma countered that the notice of side effects for patients with CV disease is a warning, not an instruction to use the product in CV patients, and that Hikma has no duty to provide a statement discouraging an infringing use.

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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. Hikma countered that the notice of side effects for patients with CV disease is a warning, not an instruction to use the product in CV patients, and that Hikma has no duty to provide a statement discouraging an infringing use.

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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. In memoriam.

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Physician's Weekly

JUNE 11, 2025

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. MemoryLane Care Services provides the museum employees with training in dementia sensitivity so they can lead tours for the memory cafe participants.

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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. Haskell, of Columbia, South Carolina, has done research and helped write AHRQ-published surveys and guidebooks on patient engagement for hospitals.

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