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Case Detail

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DistrictDistrict of Columbia
CityWashington, DC
Case Number1:2023cv02327
Date Filed2023-08-11
Date ClosedOpen
JudgeJudge Ana C. Reyes
Case DescriptionVanda Pharmaceuticals submitted three FOIA requests to the FDA for records. Vanda's first FOIA request asked for records concerning any bioequivalence study or dissolution study submitted during FDA's consideration of Teva's ANDA. The agency acknowledged receipt of the request. Vanda's second FOIA request asked for records concerning bioequivalence studies for Apotex's ANDA. The agency acknowledged receipt of the request. Vanda submitted a third request for records concerning bioequivalence studies concerning MSN's ANDA. The agency acknowledged receipt of the request. After hearing nothing further from the agency concerning any of its three requests, Vanda Pharmaceuticals filed suit.
Complaint issues: Failure to respond within statutory time limit, Litigation - Attorney's fees, Adequacy - Search

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User-contributed Documents
Docket Events (Hide)
Date FiledDoc #Docket Text

2023-08-111COMPLAINT against FOOD AND DRUG ADMINISTRATION ( Filing fee $ 402 receipt number ADCDC-10270154) filed by VANDA PHARMACEUTICALS INC.. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Summons, # 8 Summons, # 9 Summons, # 10 Civil Cover Sheet)(Hughes, Paul) (Entered: 08/11/2023)
2023-08-11Case Assigned to Judge Ana C. Reyes. (zljn) (Entered: 08/11/2023)
2023-08-112SUMMONS (3) Issued Electronically as to FOOD AND DRUG ADMINISTRATION, U.S. Attorney and U.S. Attorney General (Attachments: # 1 Notice and Consent)(zljn) (Entered: 08/11/2023)
2023-08-143LCvR 26.1 CERTIFICATE OF DISCLOSURE of Corporate Affiliations and Financial Interests by VANDA PHARMACEUTICALS INC. (Hughes, Paul) (Entered: 08/14/2023)
2023-08-184RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed as to the United States Attorney. Date of Service Upon United States Attorney on 8/14/2023. Answer due for ALL FEDERAL DEFENDANTS by 9/13/2023. (Hughes, Paul) (Entered: 08/18/2023)
2023-09-075NOTICE of Appearance by M. Jared Littman on behalf of All Defendants (Littman, M.) (Entered: 09/07/2023)
2023-09-136ANSWER to Complaint by FOOD AND DRUG ADMINISTRATION.(Littman, M.) (Entered: 09/13/2023)
2023-09-13MINUTE ORDER. Plaintiff filed this Freedom of Information Act ("FOIA") action on August 11, 2023. Dkt 1. Defendant filed its Answer on September 13, 2023. Dkt. 6. Cases filed under FOIA are exempt from the requirements of Federal Rule of Civil Procedure 26(f) and Local Civil Rule 16.3. See LCvR 16.3(b)(10). Accordingly, it is hereby ORDERED that the parties shall meet and confer and file a joint status report on or before September 27, 2023. The joint status report should address, among other things, (1) the status of Plaintiff's FOIA request; (2) the anticipated number of documents responsive to Plaintiff's FOIA request; (3) the anticipated date(s) for release of the documents requested by Plaintiff; (4) whether a motion for a stay is likely under Open America v. Watergate Special Prosecution Force , 547 F.2d 605 (D.C. Cir. 1976); and (5) whether the parties anticipate summary judgment briefing and, if so, a proposed briefing schedule. Counsel shall not contact Chambers directly concerning scheduling or other matters, as Chambers personnel will not handle questions relating to the status or scheduling of pending matters, except in case of an emergency. In an emergency, Chambers can be reached at (202) 354-3350. Signed by Judge Ana C. Reyes on 9/13/2023. (lcar3) (Entered: 09/13/2023)
2023-09-14Set/Reset Deadlines/Hearings: Joint Status Report due by 9/27/2023. (zcdw) (Entered: 09/14/2023)
2023-09-277Joint STATUS REPORT by FOOD AND DRUG ADMINISTRATION. (Littman, M.) (Entered: 09/27/2023)
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by FOIA Project Staff
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