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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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What is Salesforce Life Sciences Cloud?

Penrod

Health Cloud was a version of Salesforce CRM tailored to healthcare providers, insurance companies, and other organizations’ unique needs with patient-focused business models. Like many healthcare providers, life science companies aren’t reaching their goals for digital transformation.

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US legislative update: takeaways for European pharma

European Pharmaceutical Review

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 5) monitoring access to biosimilars.

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NeuroLogica Announces FDA 510(k) Clearance of BodyTom® 64

Legacy MEDSearch

Food and Drug Administration for commercial use in the United States. BodyTom 64 is designed and manufactured to comply with the FDA Quality System Regulations and ISO 13485:2016 requirements and is in conformance with global regulatory harmonized standards. the healthcare subsidiary of Samsung Electronics Co.,

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Prescribing shift for Pfizer’s Paxlovid expands access but draws questions

Pharmaceutical Technology

On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. The pharmacist can then review their medical history to make sure there are no concerns of drug-drug interactions with Paxlovid.

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Hemosonics Awared FDA 510(k) Clearance for Quantra® Hemostasis System with QSTAT® Cartridge

Legacy MEDSearch

Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. HemoSonics’ manufacturing, R&D, and Headquarters are based out of Durham, NC. The Quantra System’s easy and fast interpretation enables simple, more efficient point-of-care bleeding management.

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Diversity and inclusion in oncology clinical trials

Clarify Health

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. To advance equity in clinical research, the U.S. Clarify launched its real-world evidence on health disparities in 2021.