New Animal Drug Applications; Confidentiality of Data and Information in a New Animal Drug Application File
other · Food and Drug Administration · Rule · Published 2014-03-17 · Effective 2014-07-30 · 79 FR 14609
Document
Document number
2014-05430
Federal Register citation
79 FR 14609
CFR reference
21 CFR 514
Type
Rule
Action
Direct final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2014-03-17
Effective date
2014-07-30
HHS docket
Docket No. FDA-2014-N-0108
Abstract
The Food and Drug Administration (FDA) is amending its regulation regarding the confidentiality of data and information in and about new animal drug application files to change when certain approval-related information will be disclosed by the Agency. This change will ensure that the Agency is able to update its list of approved new animal drug products within the statutory timeframe. It will also permit more timely public disclosure of approval-related information, increasing the transparency of FDA decision making in the approval of new animal drugs.