Case Detail
Case Title | Natural Resources Defense Council, Inc. v. United States Food and Drug Administration | ||||||||||||||||||||||||||||||||||||
District | Southern District of New York | ||||||||||||||||||||||||||||||||||||
City | Foley Square | ||||||||||||||||||||||||||||||||||||
Case Number | 1:2013cv08635 | ||||||||||||||||||||||||||||||||||||
Date Filed | 2013-12-04 | ||||||||||||||||||||||||||||||||||||
Date Closed | 2014-01-16 | ||||||||||||||||||||||||||||||||||||
Judge | Judge Alvin K. Hellerstein | ||||||||||||||||||||||||||||||||||||
Plaintiff | Natural Resources Defense Council, Inc. | ||||||||||||||||||||||||||||||||||||
Case Description | NRDC requested FDA disclose 34 pages of the Review and Evaluation of Pharmacology and Toxicology Data for Colgate Total toothpaste, which contains triclosan, since the data had been redacted from the publicly available new drug application appearing on the agency's website. NRDC also requested a public interest fee waiver. FDA made a preliminary determination, disclosing a redacted version of the pages. The agency withheld information about the titles of studies under Exemption 4 (confidential business information). NRDC objected to the agency's preliminary determination, but the agency had taken no further action before NRDC filed suit. Complaint issues: Failure to respond within statutory time limit, Litigation - Attorney's fees | ||||||||||||||||||||||||||||||||||||
Defendant | United States Food and Drug Administration | ||||||||||||||||||||||||||||||||||||
Documents | Docket Complaint | ||||||||||||||||||||||||||||||||||||
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