Pink Sheet Podcast: US FDA Announces Coronavirus Containment Strategy, Issues Updated Type 2 Diabetes Guidance
Pink Sheet reporter and editor consider the fall-out from the FDA decision to cancel meetings and postpone inspections due to the coronavirus pandemic, as well as look at the new cardiovascular recommendations for Type 2 diabetes drug development.
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Virtual kick-off meetings may be necessary, but preparations continue in anticipation of the formal talks to reauthorize the prescription drug, generic drug and biosimilar user fee programs.
Agency officials can now discuss the ideas that have been accepted, though not in great detail.
Likelihood of webcast-only advisory committee meetings may depend on the extent of the coronavirus outbreak, Office of New Drugs Director Peter Stein tells the Pink Sheet in an interview.