Hello, I am looking to understand the need for a CE mark on a product that will be distributed to the US only but the manufacturer is in the EU. They will private label their product with the US branded read more
There’s limited regulatory guidance on gene therapies for many drug manufacturers and how it can be a struggle to develop successful strategies for CMC. At this upcoming RAPS workshop, @Janmeet Anant read more
The Commission has harmonized the next group of standards for the purpose of Europe's MDR and IVDR Article 8 harmonized standard provisions. For the MDR, these are harmonized standard entries No. read more
Hi William, Our findings will be published in Therapeutic Innovation & Regulatory Science. I'll follow up when this is published. Please stay posted! Thanks, Blake ------------------------------ read more
Hi Sushma, Is your product already placed on the market in Israel ? or do you plan to register a new product? The guidance for registration can be found in the Ministry of health website in the following read more
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Hello, I am looking to understand the need for a CE mark on a product that will be distributed to the US only but the manufacturer is in the EU. They will private label their product with the US branded distributor info but are keeping the CE mark ...
T here’s limited regulatory guidance on gene therapies for many drug manufacturer s and how i t can be a struggle to develop successful strategies for CMC. At this upcoming RAPS workshop , @Janmeet Anant will ...
The Commission has harmonized the next group of standards for the purpose of Europe's MDR and IVDR Article 8 harmonized standard provisions. For the MDR, these are harmonized standard entries No. 18 through 25 and they relate to medical gloves, biological ...
This message was posted by a user wishing to remain anonymous If multiple labs are conducting the same CTA testing for a global clinical trial, can some labs use different equipment if they don't have that specific equipment in their lab?
India’s National Cancer Grid (NCG) has sparked industry interest with its innovative approach to drug procurement. The pilot project, involving 23 cancer centers within the NCG network, successfully negotiated prices for 40 crucial oncology drugs, leading ...
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