When does the FDA put the IND on clinical hold?

If the FDA does not put an IND on clinical hold up to 30 days of receipt; it is assumed that the Phase I clinical trial can begin. The FDA puts an IND on clinical hold if it reviews an IND and finds that the information necessary and appropriate to give the FDA the confidence about the quality of the product is inadequate or unavailable. 

When the FDA puts an IND on clinical hold, the sponsor cannot go ahead with its clinical program. The criteria under which the FDA places an IND on clinical hold have been set out in its Guidance for Industry, the “INDs- Approaches to Complying with CGMP During Phase I”.

All the requirements for meeting the cGMPs with which clinical trial sponsors must comply have been set out by the FDA in its Final Rules of January 2006, which specified that most pharmaceutical products (including biologics) produced for use in Phase I clinical trial studies were exempted from complying with GMP requirements. 

Further, Section 501(a)(2)(B) of the FD&C Act mandates drugs, including IND products, to comply with cGMPs, and to be manufactured in compliance with cGMPs, failing which, they are deemed adulterated.

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