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Fixing pulse oximeters requires federal might and possible legal action, researchers say

STAT

Work by device manufacturers to improve the performance of pulse oximeters on people with darker skin has progressed little since the Food and Drug Administration asked manufacturers in 2013 to voluntarily test the devices on more diverse skin tones, according to a study published Monday in JAMA.

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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog: Biosimilars

Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Under GDUFA III alone, DPD published 32 GDUFA guidance documents and MAPPs to ensure the successful implementation of GDUFA.

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AI-driven drug discovery, precision medicine, and sustainable manufacturing can redefine the pharma industry

Express Pharma

Indian companies will need to enhance their quality control mechanisms, data management systems, and documentation practices to comply with these demanding standards. Moving into the innovative drug space requires meeting the stringent regulatory standards of agencies like the FDA and EMA. per cent of global patents to almost 2 per cent.

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Drug Storage

RX Note

Read and document refrigerator and freezer temperatures at least twice each workday (in the morning and before the end of the workday). Importantly, do not take medicine that has changed colour, texture, or smell, even if it has not expired. An example of a buffered probe is one immersed in a vial of liquid (e.g.

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Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing

European Pharmaceutical Review

To give examples, such a work package focuses on the identification of regulations (ICH Q2 R2, 3 Q8-Q14, 4-10 FDA PAT guidance, 11 EMA Annex 15 12 ), some of which may be mainly guidance documents with recommendations and flexibility when it comes to PAT.

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Pharmacists Bridge the Gaps in Care Transitions

Pharmacy Times

Because documentation of medication lists is a key component of MTM, pharmacists are well positioned to incorporate this into transitions of care.” February 2013. Community pharmacists significantly impact these transitions through medication reviews at the point of dispensing and during medication therapy management (MTM) encounters.

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DSCSA Compliance: The Time is Now

Pharmaceutical Commerce

Stakeholders are aware that this federal law—enforced by the FDA and originally enacted in 2013 as a way to help bolster security and traceability of products passing through the pharma supply chain—has seen its share of delays and exemptions over the years. The most recent enforcement delay came Oct.