Food Leads Safety Specialization 
Legacy MEDSearch
APRIL 11, 2023
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. and projected to impact 70 million Americans by 2040.
European Pharmaceutical Review
NOVEMBER 15, 2022
As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” Takeaways from ISPE’s GAMP 5 Second Edition update.
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Impetus Digital
JUNE 8, 2022
Many people believe that this new development will lead to much better treatments, saving time on trial-and-error testing procedures before determining what works best for each patient’s unique health needs. This makes them a valuable tool in fighting climate change and ensuring that we have enough food to distribute around.
Nixon Gwilt Law
SEPTEMBER 7, 2023
Pediatric healthcare innovation companies—especially those in AR/VR/XR, Digital Therapeutics (“DTx”), Remote Monitoring, Virtual Care Management, Telehealth, and Telebehavioral health—need a deep understanding of the laws and regulations that govern this special market.
European Pharmaceutical Review
DECEMBER 22, 2022
Targeted entry of mRNA into human cells is a challenging process that requires special delivery systems to protect the therapeutic mRNA from degradation…”. Carsten Rudolph, PhD is the Chief Executive Officer and co‑founder of Ethris and the lead inventor of its SNIM® RNA Technology. US Food and Drug Administration News Release.
European Pharmaceutical Review
FEBRUARY 24, 2023
The removal/separation of impurities and ensuring the purity of biologics is essential to the safety and quality of the therapeutic. Not only can impurities lead to adverse effects in patients, but they can also introduce product variability.
Medico Reach
OCTOBER 17, 2022
Since the inception of the clinical specialization, the orthopedic industry has relied on reusable surgical instrumentation. From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. However, some specific trends demand a closer look.
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