FDA Law Blog

JUNE 11, 2023

Between 2002 and 2019, there were 768 products with pediatric labeling changes under BPCA and/or PREA. 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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FDA Law Blog

NOVEMBER 9, 2023

The requirement for prior notice originates in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). “Prior notice” informs FDA about the products it can expect to be offered for import into the country. food supply and other food-related emergencies.

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FDA Law Blog

APRIL 4, 2022

He also was General Counsel of the Regulatory Affairs Professionals Society from 1982 to 2002. National Commission for the United Nations Educational, Scientific and Cultural Organization from 1983-1985. Jim was a great companion and friend.

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PEMBlog

OCTOBER 18, 2023

Overall picture of an emerging neonatal infectious disease induced by a superantigenic exotoxin mainly produced by methicillin-resistant Staphylococcus aureus. Microbiology and immunology, 57(11), 737–745. link] Nakano, M., Miyazawa, H., Kawagishi, M., Hasegawa, T., Iinuma, Y., & Ohta, M.

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The Clinical Problem Solvers

DECEMBER 16, 2020

Comparison of cross-sectional renal function measurements in African Americans with hypertensive nephrosclerosis and of primary formulas to estimate glomerular filtration rate [published correction appears in Am J Kidney Dis 2002 Feb;39(2):444]. Am J Kidney Dis. 2001;38(4):744-753. doi:10.1053/ajkd.2001.27691

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FDA Law Blog

APRIL 20, 2022

2002), Jacobus states that the Fourth Circuit determined that a use-based approach to exclusivity was consistent with the plain language of the Orphan Drug Act. First, Jacobus explains that the Eleventh Circuit’s decision creates a circuit split between the Fourth and the D.C. Circuit “both of which upheld FDA’s use-based approach.”

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Physician's Weekly

JUNE 22, 2025

These included how well physicians demonstrated respect, listened to individuals, explained information, and spent enough time with them.

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FDA Law Blog

NOVEMBER 9, 2022

As we have done in the past for the initial and each quinquennial reauthorization of the drug and medical device user fee laws—in 1992 , 1997 , 2002 , 2007 , 2012 , and 2017 —Hyman, Phelps & McNamara, P.C. has prepared a detailed Summary and Analysis of FUFRA.

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BMJ

FEBRUARY 8, 2021

Tobacco and Marijuana Use Among US College and Noncollege Young Adults, 2002-2016. J Addict Dis. 2010 Oct;29(4):417-26. doi: 10.1080/10550887.2010.509273. PMID: 20924877; PMCID: PMC2951617. Odani S, Soura BD, Tynan MA, Lavinghouze R, King BA, Agaku I. Pediatrics. 2019 Dec;144(6):e20191372. doi: 10.1542/peds.2019-1372. 2019-1372.

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GeriPal

MAY 12, 2022

But when I retired from government service, I left Kalakkad in 2002. Eric: And at that time, so around 2002, so you had palliative care kind of localized in particular parts of India, what were the big barriers to delivering palliative care outside of those areas or even inside those areas?

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GeriPal

SEPTEMBER 1, 2022

Barbara: I think I got the PDI award in 2002 and I was teaching at that time adjunct at the school of social work where I had attended. And that really just busted the door open for me in terms of having people to talk to about what I had been seeing at the bedside and in my own practice. Eric: And how long ago was that?

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GeriPal

MARCH 2, 2023

In 2002, 1% of adults were taking gabapentinoids (gabapentin and or pregabalin). Summary Transcript Summary Gabapentin is the 10th most prescribed drug in the United States and use is increasing. 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.

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FDA Law Blog

SEPTEMBER 6, 2021

Teva submitted an ANDA in 2002, and after some complicated regulatory history, ultimately carved-out the congestive heart failure indication by way of a section viii statement. GSK had listed several patents for Coreg, including a method-of-use patent listed with the use code “decreasing mortality caused by congestive heart failure.”

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GeriPal

JUNE 23, 2022

So when I got to a residency and at that point I was in residency 1999 to 2002 and we were being taught to screen everyone no matter what. So my mother’s a social worker and she did domestic violence counseling forever. And so I was very much reared as someone with a woman’s health perspective and such.

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GeriPal

AUGUST 1, 2024

So the first diabetes prevention program was published in 2002. Emily 14:38 It’s hard to get funding for big nutrition studies, but we do have a lot of great evidence. And one of the really fantastic programs and studies that we have is the diabetes prevention program.

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