Food Healthcare Safety Specialization 
Pharma Leaders
MAY 8, 2023
The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. Nexus Pharmaceuticals stated that the regulatory approval process validates facilities’ compliance with stringent quality and safety standards.
Contrarian Sales Techniques
FEBRUARY 24, 2023
Key Initiatives for Public Healthcare, Education, And Infrastructure The Malaysian government just re-announced its Budget 2023 , highlighting various initiatives aimed at boosting the country's economy and providing support to its citizens. billion, with a focus on improving public healthcare, education, and infrastructure.
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Legacy MEDSearch
JUNE 19, 2023
The US Food and Drug Administration has approved the use of iTFlow® in blood flow analysis. The FDA approval is significant as it recognizes the safety and effectiveness of iTFlow® in analyzing blood flow through 4D Flow MRI data, with the potential to enhance diagnostic accuracy for patients with cardiovascular diseases and heart conditions.
European Pharmaceutical Review
DECEMBER 19, 2023
16 Vaccines and other drugs for rapid and safe worldwide distribution should be free from the need for special storage conditions” Vaccines and other drugs for rapid and safe worldwide distribution should be free from the need for special storage conditions. Injection Safety Fact Sheet. at 100°C for 24 hours. Pages 20-27.
Nixon Gwilt Law
SEPTEMBER 7, 2023
However, as with any emerging area of healthcare innovation, new legal and regulatory considerations arise that must be thoughtfully addressed. Beyond approval, be prepared for a higher bar in terms of safety data, clinical endpoints accepted, trial size and duration, and supplemental post-market surveillance requirements.
European Pharmaceutical Review
NOVEMBER 15, 2022
The validation of computerized systems should be focused on ‘intended use’ and scaled commensurate with the risks to patient safety, product quality and data integrity” The focus until now has too often been on compliance and not on quality. Takeaways from ISPE’s GAMP 5 Second Edition update.
LEVO Health
OCTOBER 26, 2022
Food & Drug Administration (FDA) classifies medical devices. They have regulatory controls and marketing pathways you have to follow based on the risk of your device and its overall safety and effectiveness. Class II: requires general controls and special controls with and without exemptions and poses a moderate risk.
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