Investigational New Drug Applications for Biological Products; Bioequivalence Regulations; Technical Amendment
fda-drug · Food and Drug Administration · Rule · Published 2016-03-28 · Effective 2016-03-28 · 81 FR 17065
Document
Document number
2016-06886
Federal Register citation
81 FR 17065
CFR reference
21 CFR 312
Type
Rule
Action
Final rule; technical amendment.
Category
fda-drug
Sub-agency
Food and Drug Administration
Publication date
2016-03-28
Effective date
2016-03-28
HHS docket
Docket No. FDA-2016-N-0011
Abstract
The Food and Drug Administration (FDA or Agency) is amending its regulations to update the address for applicants to submit investigational new drug applications (INDs) for biological products regulated by the Center for Drug Evaluation and Research (CDER). FDA is also amending its regulations on the criteria and evidence to assess actual and potential bioequivalence problems (bioequivalence regulations) to correct a typographical error. FDA is taking this action to ensure accuracy and clarity in the Agency's regulations.