Court Decisions, ANDA Approvals, and 180-Day Exclusivity
fda-drug · Food and Drug Administration · Rule · Published 2000-07-13 · Effective 2000-07-18 · 65 FR 43233
Document
Document number
00-17652
Federal Register citation
65 FR 43233
CFR reference
21 CFR 314
Type
Rule
Action
Interim rule; opportunity for public comment.
Category
fda-drug
Sub-agency
Food and Drug Administration
Publication date
2000-07-13
Effective date
2000-07-18
HHS docket
Docket No. 85N-0214
Abstract
The Food and Drug Administration (FDA) is issuing an interim rule to amend its regulations governing the definition of court decisions that affect the timing of certain abbreviated new drug application (ANDA) approvals and the beginning of 180-day exclusivity under the Federal Food, Drug, and Cosmetic Act (the act). The interim rule eliminates the current definition of the court decision. This change is necessitated by recent court decisions on these issues.