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Economics and risks of FDA’s Quality management maturity rating programme

European Pharmaceutical Review

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

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One world, one health: The interconnected web of antimicrobial resistance

pharmaphorum

Nursing homes, dialysis centres, and long-term acute care hospitals all see considerable misuse and overuse of antimicrobials among patients who are, by definition, immunocompromised or infirm.”. “The The FDA should, then, establish a process and clear metrics to facilitate better tracking of antimicrobial consumption in animals.

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Is Donanemab a Breakthrough Against Alzheimer’s?

The People's Pharmacy

The drug lecanemab ( Leqembi ) was recently approved by the FDA to treat early Alzheimer’s disease. Most importantly, will this anti-amyloid drug keep people out of nursing homes? Pharmaceutical companies do not know what to make of this unexpected complication. It reduced clinical decline by 27%.

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Q&A: As RSV vaccine approvals loom, regulators need to devise vaccination strategies

Pharmaceutical Technology

After a long period of inactivity in RSV vaccine development , two pharmaceutical companies are now approaching regulatory decisions for their RSV vaccines. An FDA decision is expected for the use of RSVPreF3 in adults of ages 60 years and above by May 3. Even in LICs, they do yearly checks or catch up campaigns.