FDA/Generic Communications Plan Restoring Best Of Past Practices

Vinay Prasad’s exit from the US FDA reignited conversations about integrating its drugs and biologics centers under George Tidmarsh. Those plans appear to be shelved, but the leadership transition could be an opportunity to fully realize the vision for the Oncology Center of Excellence.

The Pink Sheet viewed Stealth's complete response letter and other documents indicating the FDA appears willing to grant accelerated approval to elamipretide before a confirmatory trial begins enrolling. But the company says it needs a two-month review of the NDA resubmission to survive.

AbbVie didn’t get everything it sought from a citizen petition but may still have the upper hand over smaller rivals after FDA gives makers of animal-derived thyroid medications a year to seek approval. If the agency removes compounded products, it could face more pricing pushback.

The findings are consistent with some other research and likely are due to obesity patients becoming more connected to needed health care services.