(Reuters) -The U.S. Food and Drug Administration said on Wednesday that it has launched a pilot program to give drugmakers faster answers to follow-up questions after formal meetings with the agency. Under the program, companies can email a single clarification question about feedback they receive from an FDA review group, and staff will aim to […]
Health
US FDA tests faster follow-up process for drug reviews
Audio By Carbonatix
(Reuters) -The U.S. Food and Drug Administration said on Wednesday that it has launched a pilot program to give drugmakers faster answers to follow-up questions after formal meetings with the agency.
Under the program, companies can email a single clarification question about feedback they receive from an FDA review group, and staff will aim to respond within three business days, the agency said.
The pilot is being run by the agency’s Office of New Drugs since October and has already led to several clarifications for companies after they received official meeting notes, the FDA said.
FDA commissioner Marty Makary said in a statement, “Our goal is to give sponsors prompt, clear feedback so they can focus on what they do best.”
The regulator said it plans to extend the approach to other parts of the agency over time.
(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Vijay Kishore)