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CDC releases field-tested guidance for hospital CEOs tackling their workers' mental health

Fierce Healthcare

The Centers for Disease Control and Prevention (CDC)’s campaign against healthcare worker burnout took a step forward this week with the release of a new instructional guide for executive-level hos | The free resource was developed alongside the Dr. Lorna Breen Heroes' Foundation and informed by a six-month, six-hospital pilot across CommonSpirit (..)

Hospitals 133
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New manufacturing facility could drive gold standard in cell therapy

European Pharmaceutical Review

A new Denmark-based manufacturing facility is set to establish the final development steps and upscaling of cell therapies. Partly due to this and due to the explorative phase cell therapy is in, it is very expensive to develop and manufacture cell therapies, so there simply are not many facilities doing it.”

Hospitals 109
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FDA issues draft guidance on alternative tools for facility assessments

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has published draft guidance on how it intends to use alternative tools for assessing drug manufacturing facilities identified in pending marketing applications. Fundamentally, this approach will establish whether facilities meet applicable requirements for FDA approval and licensure decisions.

FDA 93
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CDC calls for hospitals to 'raise the bar on sepsis care' with new program guidance

Fierce Healthcare

Sepsis is a factor among roughly 1 in 3 hospital deaths, yet, as of last year, more than a quarter of hospitals didn’t have a formal sepsis committee in place and nearly half said they did not prov | The agency's Hospital Sepsis Program Core Elements is a free resource center for hospitals beginning or refining their efforts to identify and address (..)

Hospitals 104
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STAT+: FDA efforts to oversee foreign drug manufacturing remain inadequate to ensure safety, analysis finds

STAT

In the wake of the Covid-19 pandemic, the Food and Drug Administration inspected far fewer domestic and foreign pharmaceutical facilities, even though manufacturing activity did not decline, according to a new analysis. Europe, India, and China, although there was a slight pullback last year in India and China.

FDA 88
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Opinion: Hospital financing in black and white

STAT

The resources for patient care and comfort were sumptuous in some facilities, spartan in others. During our training as doctors, we have rotated through safety-net hospitals, elite academic medical centers, and private clinics. While the 1964 Civil Rights Act forbade hospitals from discriminating based on race, segregation persists.

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Improving Facilities in an Efficient Manner (PDA/FDA Joint Regulatory Conference 2023)

BioPharm

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses how to upgrade facilities in an efficient manner and other highlights from his presentation.

FDA 52