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FDA Authorizes Marketing of MISHA™ Knee System for People Suffering from Knee Osteoarthritis

Legacy MEDSearch

Food and Drug Administration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. Chief, Hip and Knee Division of Sports Medicine Institute, Hospital for Special Surgery in New York.

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Rare Disease Day 2024: Advocating for Awareness and Support

PM360

This February we celebrate the 16th annual Rare Disease Day , established in 2008, to raise awareness of the more than 7,000 identified rare diseases worldwide. Rare Disease Day is observed annually on the “rarest” day of the year, February 28th or 29th depending on leap years. What is a Rare Disease?

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Precision Medicine Needs an Overhaul

PM360

During the period from 2008 through 2020, the number of precision medicines in the US increased from 5 to 285. Between 2015 and 2021, over a quarter of the drugs approved by the US Food and Drug Administration (FDA) were associated with specific biomarkers. All diseases are now “rare diseases”.

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GERTEIS® PACTOR® SERIES In-Line Ribbon-Strength Measurement System

Pharmaceutical Technology

The importance of ribbon density has previously been emphasized by Helen Winkle [1] from the US Food and Drug Administration (FDA) and it becomes clear then that maintaining the ribbon density by setting the correct force and gap is crucial for the final granulates. References. [1] 2] Gamble, J. et al, Pharmaceut.

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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

The original iteration of ISPE GAMP 5 was released in 2008 arriving in the nascent stages of what has become the cloud revolution and certainly before the widespread adoption of agile development methodologies, meaningful augmented reality, machine learning and artificial intelligence use cases in the life sciences industry.

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Direct to Patient Healthcare

Healthcare Success

Lee Aase: but I am my wife and I are the majority owners of a of the Management Services company whose role is to let the doctors and other practitioners do their thing, and we take care of the membership, acquisition, and all the other business stuff, the administrative stuff. What's that even for this, back in like 2008.

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The Future for Biotesting

Pharmaceutical Technology

Firstly, there is a comprehensive toxicological service for human and veterinary pharmaceuticals and biopharmaceuticals, food additives, chemicals and agrochemicals. IS: We mainly recruit our staff from local universities and special high schools. IS: Yes, we think so even if it has been a huge financial and administrative drain.