Outgoing US FDA Office of New Drugs director tells the Pink Sheet being on the outside will take some adjustment.
Once he retires from FDA next month, John Jenkins will have to consume FDA actions later than he has become accustomed to since becoming Office of New Drugs director, and he says he’ll miss being deluged with a variety of scientific and regulatory conundrums.
"I bounce every day from meeting to meeting to meeting; every one [has] interesting and complex scientific, regulatory and legal...
Recent studies show that spaceflight can significantly weaken astronauts’ immune systems, making them more susceptible to infections and health complications during and after missions. Understanding these changes is crucial for ensuring the safety of future long-duration space travelers.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
