Bioequivalence and Bioavailability Forum

Dear KiranActimus,

❝ It is a Bioequivalance Study submitted to US FDA as an ANDA Application.

ANDA application does not make it mandatory to complete a Form 1572. The form is only mandatory if the trial is run under an IND. Have a look particularly at § 312.53(c), and information on the form itself.

❝ I am working for the Investigator Side.

Obtaining a completed Form 1572 before the trial is initiated at the site is the sponsor's responsibility. So even if your trial was under IND (which is not mandatory for a BE outside of USA, even if intended for FDA submission), in the case of an inspection the delay in signing the 1572 should be an observation for the sponsor, not the site:

Before permitting an investigator to begin participation in an investigation, the sponsor shall obtain the following:
(1) A signed investigator statement (Form FDA–1572)

The aim of the 1572 is for the sponsor to obtain information from the investigator and a commitment to comply with the protocol and relevant legislation. If the sponsor insists for you to complete one now, even if the study is completed and was not run under IND, then file along with it the correspondence with the sponsor to document why it was signed so late. Once again it will be the sponsor's responsibility, not yours.

If for the next study you are asked to sign a 1572 before the trial, you have to realise that it will make you commit to comply with US regulation (particularly 21 CFR parts 50, 56 and 312), even if they are normally not applicable in your country.

Regards
Ohlbe