FDA Law

OCTOBER 24, 2023

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). However, there’s a clear shift in FDA’s approach that is noticeable from the title of the Draft Guidance, alone.

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FDA Law

FEBRUARY 2, 2023

While these changes to the IND and the biosimilarity provisions represent real changes to the words governing FDA’s authority under the FD&C Act, we think it is worth asking just how measurable and immediate an impact they will have on day-to-day decision-making of the FDA and its review staff.

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FDA Law

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. Incomplete and inaccurate records currently subject registrants to civil monetary penalties of up to $15,691 per violation.

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FDA Law

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. Incomplete and inaccurate records currently subject registrants to civil monetary penalties of up to $15,691 per violation.

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GeriPal

MARCH 24, 2023

For others, this piece, while painful to read, gave voice to what they have been feeling over the last decade – hospice has in some ways lost its way in a quest of promoting profit over care. If you are interested in signing the position statement “Core Roles and Responsibilities of Physicians in Hospice Care”, click here. Is it you, Ira?

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GeriPal

MARCH 2, 2023

This long and sordid history of gabapentin and pregabalin is beautifully described in Seth Landefeld and Mike Steinman 2009 NEJM editorial. 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. Cochrane Database of Systematic Reviews Review. Annals of IM.

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FDA Law

FEBRUARY 9, 2022

29, 2009)). Houck — The Drug Enforcement Administration (“DEA”) recently issued another Final Order revoking a pharmacy registration based on the failure of the pharmacy to meet its corresponding responsibility, more specifically, the failure to identify and resolve red flags. Holiday CVS, L.L.C. d/b/a CVS/Pharmacy Nos. 62,316, 62,341 (Oct.

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PEMBlog

MAY 24, 2023

Government. 2009 Nov;27(4):655-67, ix. 2009 Jun;21(3):196-202. This podcast episode hosted by Brad Sobolewski ( @PEMTweets ) and co-authored by Dennis Ren ( @DennisRenMD ) is all about age-appropriate non pharmacologic management strategies for agitated children. Coburn VA, Mycyk MB. Physical and chemical restraints.

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GeriPal

OCTOBER 20, 2022

For the policy buffs and policy newbies out there, we hope this podcast is an essential primer to government in action. And so there was a report in 2009 by the Institute of Medicine saying that we need to equip all of these individuals in caring for older person in an evidence based manner. We talk about: . This is Eric Widera.

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Physician's Weekly

JULY 2, 2025

Maria is among what the federal government estimates are 2.6 without legal permission — along with the providers and community workers that help them — are anxiously weighing the benefits of pushing forward with Medi-Cal applications against the risks of discovery and deportation by the federal government.

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Physician's Weekly

JULY 3, 2025

Federal government spending falls into two categories: mandatory, or spending required by existing law, and discretionary, which traditionally is allocated and renewed each year as part of the appropriations process. (For A key reason so much health policy has passed this way has to do with how Congress manages the federal budget.

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Physician's Weekly

JUNE 27, 2025

Conteh was working as a nurse in a hospital in Sierra Leone in 2009 when she learned of a lottery for visas to come to the United States. Care for 6 in 10 residents is paid for by Medicaid , the state-federal health program for poor or disabled Americans. It also operates a retirement community in Washington, D.C.

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