FDA wants to expand its information sharing with the European Medicines Agency, but is not ready to say that it could rely only on foreign data to approve manufacturing facilities.
FDA Mutual Reliance With EU On Inspections Is Slow Going
FDA still does over 40% of its inspections in Europe even as it acknowledges it must spend the money elsewhere.
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With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.
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The biotech CEO said the Trump Administration’s treatment of FDA employees, including the HHS secretary’s comments about industry capture, are insulting to agency staff, but he is encouraged by FDA Commissioner Martin Makary’s talk of a new conditional approval pathway.
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Two US FDA advisory committees will discuss results from epidemiological studies that attempted to quantify the prevalence, incidence and risk factors for misuse, abuse, overdose and death with opioid analgesics.