What is the FDA doing with my IND during the 30 days after it is received?
Upon receipt your application is distributed to FDA personnel who conduct reviews on all Phases of clinical trials for safety and the rights of subjects. Phase 2 and 3 studies are also reviewed to determine that the quality of the scientific evaluation of drugs is adequate to permit an evaluation of the drugs effectiveness and safety. (21 CFR 312.22) Prior to the 30 day deadline, the FDA will notify you if they determine that it is either 1) safe to proceed; 2) safe to proceed but additional information is requested; 3) not safe to proceed and the IND is placed on hold until FDA concerns are satisfactorily addressed. An investigator may proceed with his/her investigation 30 days after FDA has received the IND application if no communication is received from the FDA. See 21 CFR 312.40. Note: FDA will notify the investigator of the date of receipt. It is not uncommon for FDA to provide communication only for items #2 and #3 above.
