All Marty Makary articles
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NewsFDA revises PK study approach in new biosimilar draft guidance
Sandoz is also adjusting its global strategy by recruiting Armin Metzger as President of Biosimilar Development, Manufacturing & Supply.
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NewsVinay Prasad to exit CBER as FDA group director
US agency is set to see another new face take the helm, following Dr Prasad’s departure at the end of April.
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NewsFDA policy sets new clinical trial requirements for drug approvals
The default standard would see US drug and biologic approvals require a single, robust pivotal study plus confirmatory evidence, instead of two trials.
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NewsFDA launches PreCheck pilot programme for US pharma manufacturers
The regulator’s new programme aims to create more efficient regulatory review processes for new pharmaceutical manufacturing facilities.
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NewsFDA appoints another new CDER director, selecting Dr Tracy Beth Høeg
She will become the fifth leader at the Center, following the surprise retirement decision by her soon-to-be predecessor Richard Pazdur.
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NewsFDA names Dr Richard Pazdur to replace George Tidmarsh as CDER Director
The FDA-veteran and oncology specialist will lead the US drug agency’s work ensuring the safety and efficacy of medicines.
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FDA draft guidance on biosimilars offers “regulatory relief”
US agency follows in footsteps of European Medicines Agency (EMA) in efforts to streamline biosimilar development.
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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 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 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, boosting its active pharmaceutical ingredient production capacity.
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NewsVinay Prasad returns to lead vaccines and cell and gene therapy at the FDA
CBER head makes surprise comeback just weeks after his abrupt resignation.
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NewsFDA to encourage new manufacturing sites with its PreCheck programme
The scheme will provide more support and a streamlined application process to companies constructing new US facilities.