FDA Law Blog

APRIL 8, 2025

OGDP is one of several offices in OGD, and it was composed of three divisions: the Division of Legal and Regulatory Support, the Division of Orange Book Publication and Regulatory Assessment, and the Division of Policy Development (DPD).

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Doctor Rachel

JULY 21, 2019

He is recovering well, but once he was on the mend, I “hit the wall” emotionally last week and was sent into the wilderness for retreat by my sweet husband. It was just what I needed. I really got it that this beautiful chosen land that I live in, can heal me as deeply as any land in the world. Healing ourselves requires healing the earth.

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Today's Hospitalist

MAY 16, 2025

A struggle for enough staffing When the federal government launched the readmission penalty program in 2013, staff with OSF HealthCare knew their readmission rates fueled by bouncebacks from SNFs were running between 18% and 25%. Contracting with an outside company brought the coverage and care coordination needed to prevent readmissions.

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Medical Xpress

FEBRUARY 16, 2023

Those were some of the questions first posed in 2013 after a landmark discovery by UC San Francisco neuroscientist Jonah Chan, Ph.D., What if an over-the-counter allergy medicine could help halt and even reverse multiple sclerosis? And if it did, could patients return to their full capacity? and physician-scientist Ari Green, MD.

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FDA Law

JUNE 26, 2025

Actavis decision in 2013 total $423 billion, and the average savings to the healthcare system per molecule are $5 billion.” And now we have a pretty comprehensive data set from the IQVIA Institute to show the positive effects of patent settlement agreements. We all know that time is money. 

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FDA Law Blog

JUNE 2, 2025

The letter, which FDA issued on March 31, 2025 (but only posted on its website last week), was only one of two that FDA has sent in the last five years and only one of five that FDA has issued since finalizing its RUO Guidance in November 2013 (see guidance here ).

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PEMBlog

OCTOBER 11, 2023

2013 Jan;189(1):288-93. 2013 Apr;32(2):239-46. Epub 2013 Feb 8. The bladder is a hollow organ and therefore is relatively protected when empty, which makes rupture uncommon. However, in pediatric patients whose pelvic bones are not fully developed, the bladder is more prone to injury. doi: 10.1016/j.juro.2012.09.003.

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Annals of Family Medicine

NOVEMBER 20, 2024

Setting or Dataset: A dataset was used, consisting of 350 long-term female breast cancer survivors included between 2013 and 2016 in general practices in the Netherlands. This ideally should be detected in primary care, since most specialist follow-up care for breast cancer is discontinued after five years. and a specificity of 66.6%

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PEMBlog

OCTOBER 31, 2024

Pediatrics, 2013. 2013 Sep;38(5):467-76. Epub 2013 Jul 10. There were also no differences in the duration of diarrhea or vomiting, day-care absenteeism, or household transmission of symptoms. Caution While this study provides important insights, it is worth noting that probiotics may still play a role in other health contexts.

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Annals of Family Medicine

NOVEMBER 20, 2024

published the Team Development Measure (TDM) in 2013. Context: Prior research suggests that effective team dynamics correlate with enhanced clinical outcomes, diminished medical errors, and mitigate burnout. Stock, et al. It is a 31-item scale developed in primary care settings and has been demonstrated to be reliable and valid.

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Annals of Family Medicine

NOVEMBER 20, 2024

Setting: Criteria Time Frame: 2013-01-01 to 2023-12-31. Study Design and Analysis: Retrospective chart search of the electronic medical records of a specific sub-group of patients at UNMC. Number of patients who meet inclusion criteria at Family Medicine Clinics: 6,551 Patients. are Not Hispanic or Latino and 87.7% are White or Caucasian.

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Myriad Genetics

FEBRUARY 21, 2024

1 , 1–15 (2013). “We started asking questions because he still wasn’t walking. We went through the pediatrician, the physical therapist, and none of those people brought up carrier screening. It was something that I found on my own.” Ashley’s journey to a diagnosis for Christopher probably felt like forever to their family. & Boice, N.

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Medical Xpress

APRIL 28, 2023

The Harlem Shake is on the radio and e-cigarettes are becoming a thing. A group of researchers convene to discuss these and other products containing nicotine.

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Physician's Weekly

JUNE 24, 2025

1, 2013, weren’t eligible for vaccination, but those even slightly younger were eligible. Kim Beckham, an insurance agent in Victoria, Texas, had seen friends suffer so badly from shingles that she wanted to receive the first approved shingles vaccine as soon as it became available, even if she had to pay for it out-of-pocket.

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Medical Xpress

JANUARY 17, 2023

The My Life, My Story (MLMS) project was established through the Veterans Health Administration in 2013 with the goal of bringing the patient's voice into their medical record.

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Aspiring Minority Doctor

OCTOBER 23, 2021

If you've been following my blog since it's inception in 2013, then you already know how much of an inspiration Dr. Barbara Ross-Lee is to me. #OMED21 Smiles I have had quite a few full circle moments over the past few years, but the one I experienced today compelled me to write this post. And guess who led the session? How crazy is that?!?!

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FDA Law Blog

AUGUST 2, 2022

Within the last month, the Cannabis Regulators of Color Coalition (“CRCC”) and handful of Democratic Senators have separately reached out to Biden Administration officials, including Attorney General Merrick Garland, requesting action to mitigate or eliminate federal prohibition on the use of cannabis. 21 U.S.C. § 812(b)(1). 26, 2022).

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FDA Law Blog

DECEMBER 1, 2024

To be clear, as we discussed in a blogpost back in 2013 , the Federal Food, Drug, and Cosmetic Act does not explicitly require companies to permit photographs to be taken. . Farquhar — A recent Warning Letter reflects an FDA citation of a company for refusing to permit FDA Investigators to take photographs during an inspection.

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Sound Physicians

OCTOBER 30, 2024

I went to the University of Toronto and finished my Bachelor of Science there in 2013. I was born and raised in the Middle East, Saudi Arabia, before immigrating to Toronto with my family. It was my father’s dream to have a child become a physician, and his support motivated me to pursue medicine.

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ABIM

JUNE 12, 2025

Since 2013, ABIM Specialty Boards have been required to include at least one physician member primarily engaged in community practice, defined broadly in applications as “clinical practice in a non-university, community setting.” 4,372 of these (92%) also have a current valid certificate in Internal Medicine.

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FDA Law Blog

MAY 2, 2022

Attorneys in August 2013 that DOJ was unlikely to take enforcement action against marijuana-related businesses operating in compliance with state law unless the businesses implicated any one of eight enforcement priorities. 29, 2013 , 3. Cole, Memorandum for All United States Attorneys, 2013 , at 1-2. 26, 2022, (01:06:35).

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PEMBlog

FEBRUARY 8, 2024

2013 Nov;32(11):1295-6. Just look at the rash – then scroll down to reveal the diagnosis. That’s it. This is a baby with swollen, erythematous skin of the chest wall. It’s Neonatal Mastitis! This is a skin and soft tissue infection of the breast tissue in a newborn. The treatment is directed towards S. Pediatr Infect Dis J.

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FDA Law Blog

JUNE 30, 2022

The FDA’s proposed licensing rule would implement a long-awaited provision of the 2013 Drug Supply Chain Security Act (“DSCSA”) that establishes the requirement for national license standards for WDDs and 3PLs. 6,708 (Feb. These preemption provisions apply to state and local licensure standards, requirements, and regulations. 1) In general.–Beginning

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Aspiring Minority Doctor

JUNE 1, 2022

My intent this year was to at least update everyone at the end of every month, but work and life distracted me from my favorite hobby of writing. I'll try my best to catch everyone up with this post, and for the sake of time, I'll try to keep it relatively brief since I know I can get a bit wordy. I love my Plastic Surgery residency family!

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GeriPal

APRIL 27, 2023

Palliative Care the Next Generation: How the Service May Grow and Evolve AccentCare , a portfolio company of private equity firm Advent International, is another example. The company has expanded its palliative care services through partnerships with hospitals and other managed care providers, according to AccentCare CEO Stephan Rodgers. Eric: Yeah.

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FDA Law Blog

JULY 7, 2022

Efforts to update safety standards for cosmetics have been ongoing since 2013, with the proposed Personal Care Products Safety Act of 2021 being the most recent iteration prior to FDASLA. While FDASLA focuses on user fees and includes several other provisions regarding drugs and devices, it also includes provisions related to cosmetics.

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FDA Law Blog

FEBRUARY 4, 2022

The Drug Supply Chain Security Act (“DSCSA”), enacted back in November 2013, directed FDA to create national licensure standards for wholesale distributors and 3PLs within two years of its enactment (i.e., The comment period for the Proposed Rule will remain open until June 4, 2022 (120 days after publication). See 21 U.S.C. 360eee-4(b)(2).

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CDOCS

JUNE 3, 2021

</span></p> <p><span style="font-size:14px;">Greg came to my practice initially in 2013 as a new patient. We can&rsquo;t force a patient to follow the right sequence and often times we have to make compromises to achieve a stable and healthy dentition. I present to you Greg.</span></p>

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Patients Treatment Plan IT Diagnose 52

ABIM

APRIL 24, 2025

Since 2013, ABIM Specialty Boards have been required to include at least one physician member primarily engaged in community practice, defined broadly in applications as “clinical practice in a non-university, community setting.” Representatives from the American College of Rheumatology (ACR) joined for a portion of the meeting*.

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FDA Law Blog

AUGUST 8, 2024

Will DOJ and DEA continue to exercise the enforcement discretion generally shown since the Cole Memo was issued in August 2013? While DEA is the primary federal authority that enforces the CSA and its regulations, the states, commonwealths, and territories also regulate marijuana and other controlled substances within their borders.

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FDA Law Blog

DECEMBER 13, 2023

However, our research reflects that of the orphan-designated novel drugs approved since 2013 by DRDMG or its predecessor, the Division of Gastroenterology and Inborn Errors Products (DGIEP), only 1 out of 18 went to an advisory committee meeting. Note that FDA is currently soliciting applications to staff this committee.

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FDA Law Blog

APRIL 26, 2021

Koblitz — So-called “Pay-for-Delay” settlements, also called Reverse Payment, settlements—in which an innovator sponsor pays a generic sponsor to settle ongoing patent infringement litigation in exchange for a delay in generic market entry—have been fodder for antitrust concerns for decades (see, for example, our coverage from 2013 ).

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FDA Law Blog

APRIL 26, 2021

So-called “Pay-for-Delay” settlements, also called Reverse Payment, settlements—in which an innovator sponsor pays a generic sponsor to settle ongoing patent infringement litigation in exchange for a delay in generic market entry—have been fodder for antitrust concerns for decades (see, for example, our coverage from 2013 ).

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GeriPal

JANUARY 12, 2023

Which patients are eligible to go to an ACE unit? What are the benefits of an ACE unit? If ACE units are so great, why are they not so common? . What does the future look like for ACE units and how does it differ (if at all) from Age Friendly Health Systems? But before we do, do you have a song request? I think Kellie, do you have it? Alex: Yeah.

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Hospital Patient-Centered IT Nurse Practitioner 101

FDA Law Blog

AUGUST 19, 2021

Moore — In a repeat of 2013 , 2015 and 2018 , Rep. By Karin F.R. Frank Pallone (D-N.J.) has yet again introduced the Food Labeling Modernization Act (FLMA). As in the past, there are a few new things of note, and a few other things have been removed (e.g., requirements for sesame allergen labeling, which was accomplished earlier this year).

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FDA Law Blog

JUNE 17, 2024

OPQ reports that the vast majority of the 81 drug shortages reported in CY2022-23 were due to quality issues (40%) and increase in demand (40%)—a significant change from 2013-2017 when quality issues were the cause of 62% of shortages. are safe, effective, and meet appropriate quality standards. Every American consumer expects the U.S.

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FDA Law Blog

JUNE 29, 2022

Livornese — Last week, FDA issued a draft guidance entitled “Considerations for Rescinding Breakthrough Therapy Designation” (the Draft Guidance ), authored by CDER, CBER, and the Oncology Center of Excellence (it is interesting, though not surprising, to see the OCE as an author on this document, given the popularity of the program in oncology).

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