FDA Law Blog

AUGUST 21, 2023

Investigators also found that the pharmacy sold pseudoephedrine (“PSE”) products but failed to self-certify in violation of the Combat Methamphetamine Act of 2005 (“CMEA”). Austin Pharmacy to Pay $200,000 in Civil Penalties for Alleged Violations of the Controlled Substances Act, Aug. 16, 2023 ( DOJ Press Release ). 21 U.S.C. §

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PEMBlog

AUGUST 7, 2023

197-210; 2005. In children aged 2 to 5 years adenotonsillectomy has an 80% success rate if there is adenoid and tosillar hypertrophy. CPAP is an option for children older than 6 years (they can tolerate it better at that age). Weight loss strategies are employed for overweight children. References Carole L. Marcus , Lee Jay Brooks , Kari A.

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FDA Law Blog

JUNE 11, 2023

This Draft Guidance, in part, replaces a 2005 guidance titled “How to Comply with the Pediatric Research Equity Act.” However, given FDA’s prior announced policy, it is somewhat surprising that only 16% of pediatric labeling changes pursuant to BPCA and/or PREA between 2002 and 2019 were conducted under both the BPCA and PREA.

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PEMBlog

SEPTEMBER 26, 2024

Infantile cortical hyperostosis, also known as Caffey’s disease, is an autosomal dominant genetic condition linked to a mutation in the COL1A1 gene which encodes type I collagen. It causes changes in bones which typically begin in infancy and self-resolve by two years of age. It most often affects the mandible and long bones. Mäkitie, O.,

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FDA Law Blog

MAY 23, 2023

By Sophia R. Gaulkin & Riëtte van Laack — On May 16, the U.S. Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact.

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PEMBlog

AUGUST 20, 2024

2005 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. ECPR involves using ECMO (Extracorporeal Membrane Oxygenation) to take over heart and lung functions, offering a last-resort option that is becoming more common in large pediatric hospitals. Stratton, M., & Edmunds, K.

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FDA Law Blog

NOVEMBER 9, 2021

We hope you don’t need to copy over “Road Jamz 2005,” as John Oliver worried about in his episode of Last Week Tonight that addressed this important issue as it related to submission of Emergency Use Authorizations early in the COVID-19 pandemic. Draft Guidance at 8.

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FDA Law Blog

FEBRUARY 28, 2023

Lenz, Principal Medical Device Regulation Expert — Since 2005, 510(k) submissions have been formatted according to FDA guidance Format for Traditional and Abbreviated 510(k)s. By Adrienne R. The guidance describes twenty sections to be included in a Traditional or Abbreviated 510(k). Learnings on how eSTAR works Starting Too Early.

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GeriPal

NOVEMBER 17, 2022

We additionally firmly establish that the song How to Save a Life by the Fray was a product of the aughts (2005, to be exact), not the 90’s ): Enjoy! AlexSmithMD (still on Twitter at present). Transcript. Eric: Welcome to the GeriPal podcast. This is Eric Widera. Alex: This is Alex Smith. And which journal again? Eric: JAMA Network Open.

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FDA Law Blog

NOVEMBER 22, 2021

Like the 2005 guidance, this new draft guidance applies to all types of premarket submissions, but now the Agency has specifically added De Novo Classification Requests and Biologics License Applications (BLA). To put the age of the existing guidance into perspective, it was published two years before the first iPhone was released.

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The Clinical Problem Solvers

OCTOBER 11, 2021

London: Routledge; 2005. We tend to think of health inequities as big, monolithic, deeply entrenched patterns, and they are, but their variability is really important. It gives us a sense of how different things can be.”-Professor Professor DeMaio notes that confusion around terminology is not a reason to shy away from discussions around it.

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GeriPal

NOVEMBER 2, 2023

I’ve seen this question come up a lot since finishing fellowship nearly two decades ago. Historically, answers generally lamented the ever increasing need for geriatrics without a corresponding growth in the number of specialists in the field. Mike, welcome to GeriPal. Mike: Great to be here. Alex: We’ll take any Warriors we can get.

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The Clinical Problem Solvers

DECEMBER 20, 2021

[link] CPSolvers: Anti-Racism in Medicine Series Episode 13: Centering Asian Americans: Racism, Violence, and Health Show Notes by Naomi F. Fields December 21, 2021 Summary: This episode is about racism faced by Asian-Americans, why it often goes unrecognized, and how we can work to rectify these wrongs. link] The Practice (2019).

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GeriPal

SEPTEMBER 12, 2024

Well-being committees are popping up at every level of an organization. And C-suites now have chief wellness officers sitting at the table. Eric 01:54 Why’d you pick this song, Naomi? Naomi 01:57 Because it really talks about this beautiful experience of our beloved, which is ourselves, the part that we often cut out of the equation.

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PEMBlog

DECEMBER 14, 2023

2005 Nov;128(5):3391-7. 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. Isaac A, Zhang H, Soon SR, Campbell S, El-Hakim H.

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Diagnosis IT Diagnose Patients 52

GeriPal

DECEMBER 29, 2022

Dealing with conflict in caring for the seriously ill: “it was just out of the question” JAMA 2005. Conflicts Experienced by Caregivers of Older Adults With the Health-Care System. Journal of Patient Experience. December 2020. Transcript. Eric: Welcome to the GeriPal Podcast. This is Eric Widera. Alex: This is Alex Smith.

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Physician's Weekly

JUNE 12, 2025

In a 2005 article for Rolling Stone that was later retracted, Kennedy claimed government officials had buried data showing a link between vaccines and autism, The Wall Street Journal said. It’s unclear if he has regained access. It added that “HHS will follow the science — wherever it leads.” But some public health leaders are concerned. “He

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Pamela Wible MD

JUNE 19, 2025

Open since 2005 her community clinic has inspired Americans to create ideal hospitals and clinics nationwide. Physician burnout describes a dangerous mix of emotional exhaustion, depersonalization, and a loss of meaning in work. But is it really burnout—or something more serious? Thank you for joining us Dr. Wible. To be real. Think about it.

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Physician's Weekly

JUNE 25, 2025

When Sturdevant first tested positive for HIV in 2005, he didn’t seek treatment. — Cedric Sturdevant woke up with “a bit of depression” but made it to church, as he does every Sunday. In a few days, he would drive from Mississippi to Washington, D.C., About 40% of adults with HIV rely on it for their lifesaving treatments.

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