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FDA draft guidance on biosimilars offers “regulatory relief”
US agency follows in footsteps of European Medicines Agency (EMA)…
US agency follows in footsteps of European Medicines Agency (EMA) in efforts to streamline biosimilar development.
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Marty Makary
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FDA to modernise review process for developers of ultra-rare diseases
The regulator’s new principles aim to ease the pathway to…
The regulator’s new principles aim to ease the pathway to regulatory approval for rare disease drug developers in the US.
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FDA starts publishing daily adverse event data
US regulator says the move to open up the FAERS…
US regulator says the move to open up the FAERS database will help modernise its safety monitoring.
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AbbVie invests $195m to expand API manufacturing in the US
The pharma company will add to its existing Chicago site,…
The pharma company will add to its existing Chicago site, boosting its active pharmaceutical ingredient production capacity.
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Vinay Prasad returns to lead vaccines and cell and gene therapy at the FDA
CBER head makes surprise comeback just weeks after his abrupt…
CBER head makes surprise comeback just weeks after his abrupt resignation.
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FDA to encourage new manufacturing sites with its PreCheck programme
The scheme will provide more support and a streamlined application…
The scheme will provide more support and a streamlined application process to companies constructing new US facilities.
