C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 312—INVESTIGATIONAL NEW DRUG APPLICATION › Subpart E—Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses

21 C.F.R. § 312.87

Active monitoring of conduct and evaluation of clinical trials

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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.

Notes of Decisions
Cited in 1 case, 2010–2010 · leading case: Mohr v. Targeted Genetics, Inc., 690 F. Supp. 2d 711 (C.D. Ill. 2010).
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Mohr v. Targeted Genetics, Inc., 690 F. Supp. 2d 711 (C.D. Ill. 2010). “” 21 C.F.R. § 312.87 . Abbott next notes that, after the successful completion of this testing regime, the applicant must submit a New Drug Application (“NDA”) or, in the case of biologic products like gene therapies, a Biologies License Application (“BLA”).”
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