This message was posted by a user wishing to remain anonymous
For a US IND application, are investigational (drug) product retains required to be held at the clinical site for a clinical study (BA/BE/ or pivotal trial)?
Per 21 CFR 320.38:
(a) The applicant of an application or supplemental application submitted under section 505 of the Federal Food, Drug, and Cosmetic Act, or, if bioavailability testing was performed under contract, the contract research organization shall retain an appropriately identified reserve sample of the drug product for which the applicant is seeking approval (test article) and of the reference standard used to perform an in vivo bioavailability study in accordance with and for the studies described in paragraph (b) of this section that is representative of each sample of the test article and reference standard provided by the applicant for the testing.
I know of a situation where a lab received a 483 observation from the FDA because they did not have retain samples of the drug product that they were running a bioequivalence study on (in vitro BE test), but am also told that clinical sites are required to return all drug product to the sponsor after the trial has ended. These seem in conflict with each other.
What is your experience in this situation? Are there situations where each applies? If so, please provide examples.
Thank you.