Since October, the US FDA has been running a trial of a program that aims to have more frequent communication with pharma companies that have drug applications pending with the agency to ease the process.
FDA Commissioner Marty Makary said that the trial has only been with a handful of companies, but has been going well. One new element is that if a drugmaker has a question, they can send it to FDA with a turnaround time within three business days.
“If they can get that clarification, it can save them months of guesswork,” Makary told Bloomberg in an interview.
While the new program is being spearheaded by the Office of New Drugs, the commissioner is aiming to expand it to its other divisions.
Makary added the agency intends to hire 1,000 new scientists and inspectors over the next few months.
Earlier this year, HHS Secretary Robert F. Kennedy Jr. announced thousands of layoffs at the FDA.
