Profile

Regina Ricciuti-Ballinger, RAC, MS, RN

Contact Details

United States

Contributions

1 to 5 of 9 total

Comments on Requirement for the Certificate of Pharmaceutical Product

Posted By Regina Ricciuti-Ballinger 07-Jun-2018 06:33
Found In Egroup: Regulatory Open Forum \ view thread
Hi Everyone I'm looking for pain points regarding the CPP. I wanted to see if I could get a session/public group together to discuss this topic. Let me know your thoughts! Gina

Question About Reporting Expected AEs under an IND

Posted By Regina Ricciuti-Ballinger 04-May-2018 13:55
Found In Egroup: Regulatory Open Forum \ view thread
Is there any time that the FDA would want a 15 day report for an "expected" AE in preclinical trials under an IND? thanks

Discussion on Recordkeeping Requirements for Recorded Phone Calls

Posted By Regina Ricciuti-Ballinger 19-Apr-2018 11:16
Found In Egroup: Regulatory Open Forum \ view thread
(j) Recordkeeping. The applicant must maintain for a period of 10 years records of all adverse drug experiences known to the applicant, including raw data and any correspondence relating to adverse drug experiences. Company A has an inhouse call center and received an external AE report. The call ...

RE: Quoting the FDA

Posted By Regina Ricciuti-Ballinger 04-Apr-2018 12:53
Found In Egroup: Regulatory Open Forum \ view thread
I would agree with this. There is no copyright given it is government material but citations according to profession are the norm. Gina

Question on Packaging and Labeling INDs

Posted By Regina Ricciuti-Ballinger 30-Mar-2018 14:38
Found In Egroup: Regulatory Open Forum \ view thread
Hi I have an investigational new drug that will be reconstituted in vials of a solvent for reconstitution prior to administration. I am supplying the solvent with the drug. When I ship them both, does the solvent have to be labeled as an IND too? Gina