The SF RAPS Chapter is hosting our Annual FDA Pacific Region Update on July 27th.
As we prepare for the event, we invite you to submit questions in advance for the FDA to answer.
Your specific questions will be categorized and grouped by subject examples below:
· Organizational changes (structure, org charts, etc.)
· Data and Trends (number of drug vs. device inspections by domestic/foreign/region, warning letters, etc.)
· Update on Regulatory Processes (developing guidance, best practices, etc.)
· Current Inspectional Observations (top 10 each - drug and device 483s)
Our plan is to post general replies as a follow-up to this discussion thread.
So go ahead SF Chapter Members: Ask FDA Anything! ... (anonymously, of course)
-------------------------------------------
Thomas Navarro RAC
SF RAPS Chapter Board Member
<st1:place w:st="on"><st1:City w:st="on">San Mateo</st1:City> <st1:State w:st="on">CA</st1:State>, <st1:country-region w:st="on">United States
-------------------------------------------</st1:country-region></st1:place>