Hi RegEx Members, November is often a month where we share what we are thankful for. Today, I wanted to share with you what I am thankful for.   On behalf of RAPS, I am thankful for… the RegEx members and this online community. Your collaborative nature and commitment to the field are what makes RegEx a truly unique and invaluable resource for ...

​​Hi RA folks, My question is with reference to change to Quality system for a medical device manufacturer. One of the change that falls underneath the Quality system change umbrella is - Change in number of employees. Does this mean like large changes in the number of employees?  How to evaluate if a change in number of employees substantially impacts ...

​I agree with the second respondent.  It is assumed that the study in the USA and being conducted under a FDA IND.  The  PI for the commercially available drug relates to the approved uses for that drug and not for any unapproved uses or combinations with other unapproved drugs.  Therefore the IRB and the Clinical Investigators need to receive additional ...