GDUFA Performance Goals For Fiscal Years 2013-2017
By the end of the user fee cycle in FY 2017, FDA expects to have cleared the backlog and be acting on un-amended ANDA submissions with 10 months.
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Pink Sheet reporter and editors discuss FDA Commissioner Martin Makary’s decision to have one of his assistants lead negotiations for Novavax’s delayed COVID-19 vaccine review, as well as some recent missed review deadlines, which may be the result of recent FDA cuts.
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.
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.
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.
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Employers and other health plan sponsors may need to push for better targeted reforms that lower cost sharing for patients.
FDA Commissioner Martin Makary's remarks that his special assistant Tracy Beth Høeg will "be involved in other approval procedures" besides Novavax's COVID-19 vaccine application could be a dramatic change in operations, potentially making the approval system unpredictable.
CEO Len Schleifer said during the company’s first quarter earnings call that most of the complete response letters the company has received related to third-party suppliers, not efficacy or safety.