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Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

FDA Law Blog

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. The government asserted additional allegations that are outside our scope. 11, 2023 ( DOJ Press Release ).

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Many Older People Embrace Vaccines. Research Is Proving Them Right.

Physician's Weekly

Deana Hendrickson, 66, who provides daily care for three young grandsons in Los Angeles, sought an additional MMR shot, though she was vaccinated against measles, mumps, and rubella as a child, in case her immunity to measles had waned. So, in 2016, she celebrated her 60th birthday at her local CVS. Kennedy Jr.,

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The ICH E6(R3) Guideline: A Major Update to Good Clinical Practice

FDA Law Blog

Meanwhile, Annex 2, which provides guidance on pragmatic and decentralized clinical trials as well as trials incorporating real-world data, is expected to be finalized by ICH later in 2025. The guideline expands its focus on data governance and clearly defines the roles and responsibilities of sponsors, investigators, and service providers.

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FOIA Requires Transparency of Instructions to FDA Staff, Even When Those Instructions Are to Pause Communications with the Public

FDA Law Blog

As the DOJ FOIA Guide explains in its introduction : The United States Supreme Court has explained that [t]he basic purpose of [the] FOIA is to ensure an informed citizenry, vital to the functioning of a democratic society, needed to check against corruption and to hold the governors accountable to the governed. 552(a)(4)(B). 552(a)(4)(B).

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Insights into the design, development and implementation of a novel digital health tool for skilled birth attendants to support quality maternity care in Kenya

BMJ

Donors, government ministries, agencies and academic partners regularly cascade requests for data that multiply and complicate the simple interaction into a complex, and often redundant, set of data requirements for the same singular interaction. Mobile phone penetration has finally exceeded 90% in low- and middle-income countries.

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Podcast: AI, innovation, and value-based care in medicine

Permanente Medicine

Nguyen shared the multiple benefits of an AI ambient listening tool — recently rolled out nationally to more than 25,000 Permanente physicians — that transcribes office visits (with patient consent) that can be edited and added to electronic health records. Innovation thrives when you get multiple diverse perspectives.”

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Screening for Dementia: A Podcast with Anna Chodos, Joseph Gaugler and Soo Borson

GeriPal

Joe 03:55 You know, my thoughts are screening is important for a variety of reasons, and certainly Doctor Boris and Soo and Anna, Doctor chodos can provide a lot greater clinical insight than I. Are there, though, populations that it may be helpful in, or should that change with the advent of the new amyloid antibodies? Should it?

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