Pink Sheet Podcast: Election Fallout, IRA Impacting Product Development, Updated US FDA Expanded Access Policy
Pink Sheet reporters and editor discuss the impact of the midterm elections, the Inflation Reduction Act’s effects on drug development, and adjustments to FDA expanded access guidance.
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Beginning confirmatory trials before the accelerated approval is granted shortens the time between clearance and the confirmation of benefit, when patients are at risk, said Oncology Center of Excellence Director Richard Pazdur.
Successive waves of Alzhiemer’s therapies are going to be needed, David Ricks said as his company awaits Phase III data on donanemab, the last of three late-stage anti-amyloid drugs to report results.
Final guidance excludes stool banks, putting in place more limited enforcement discretion regarding the requirement of an investigational new drug application for use of fecal transplants to treat C. diff infections, likely paving way for shift to any FDA-approved product.