Biotech companies looking to develop or market their products in the EU can benefit from the European Commission’s biotech and manufacturing hub, which it said was an “operational tool for easy and accessible information on the relevant EU legislation, financing opportunities and business support networks.”
EU Launches Biotech Hub With ‘Critical Information’ About Regulations & Funding
The European Commission’s new biotech and biomanufacturing hub will make it easier for innovative biotech companies to find legislative documents, funding information and guidance to help them bring new products to the market.
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The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
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The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.
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A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.
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A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.
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US FDA Commissioner nominee Martin Makary is being embraced by industry, and Senate Democrats, as a more traditional pick than other Trump Administration nominees, but the Make America Healthy Again agenda still is clearly coming to the agency.