CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE (parts 300 to 370) > PART 312—INVESTIGATIONAL NEW DRUG APPLICATION > SUBPART E—Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses (§312.80 to §312.88) > 312.87—Active monitoring of conduct and evaluation of clinical trials.

312.87—Active monitoring of conduct and evaluation of clinical trials.

For drugs covered under this section, the Commissioner and other agency officials will monitor the progress of the conduct and evaluation of clinical trials and be involved in facilitating their appropriate progress.