FDA/industry compliance task force
This article was originally published in The Gray Sheet
Executive Summary
The agency's Office of Regulatory Affairs is deciding whether to implement the task force's proposal to allow manufacturers a prescribed amount of time to respond to an FD-483 report before the agency issues a warning letter ("The Gray Sheet" March 16, p. 14), industry reps say. The "grassroots" task force had proposed giving firms 15 days to respond before a warning letter went out. The group is expected to meet this fall in Rockville, Maryland to discuss development of a questionnaire for FDA inspectors and inspected companies to offer feedback on the agency's practices of preannounced inspections, annotated 483s and warning letter "close-out" correspondence; methods of keeping agency field personnel up to date on emerging technologies; and development of additional guidance on submitting premarket submissions to FDA