US FDA's Office of New Drugs has been without a permanent director for more than a year as it undergoes a significant restructuring.
The US FDA's Office of New Drugs could have a new director by the end of the year that could potentially compete its ongoing restructuring effort.
Center for Drug Evaluation and Research Director Janet Woodcock told the Pink Sheet May 3 following a presentation at the Food and Drug Law Institute Annual Conference that the new director could be in place within six months, which
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.
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.
