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

FDA Law

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. By Larry K. Zarzamora Press Release.

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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

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).

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

FDA Law

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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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. “I’m sort of hectoring,” she acknowledged. The nation’s health secretary, Robert F.

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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. It’s around providing the best value. million members and patients.

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As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement

FDA Law

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well. By John W.M.