Legal Opinion
United States v. Barr Laboratories, Inc.
District Court, D. New Jersey
Decided March 30, 1993No. Civ. A. 92-1744PublishedCited by 13 opinions
1Opinion of the Court
Table of Contents
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BACKGROUND . rfi.
I.FINDINGS OF FACT .
A. The Parties.
B. The Regulatory Scheme . CR
C. FDA Investigatory Practice. OI
D. Drug Testing Overview. Oí
1. Failures. Oi
2. Failure Investigations.
3. Outliers.
Retesting. Page 469
Resampling. 470
Remixing. 471
Averaging. 471
Releasing a Batch for Distribution. 471
Blend Testing. 472(a) Sample Size. 472(b) Site of Sampling. 474
E. Criticisms of Barr. 474
1. Manufacturing Process Validation . 474(a) General Requirements. 474(b) Specific Process Problems . 475(1) Batch Failures. 475(2) Retrospective Validation. 476(a) Omitting Failing Results.…
2Cases cited21 opinions
- Weinberger v. Romero-BarceloSupreme Court of the United States · 1982
- Instant Air Freight Co. v. C.F. Air Freight, Inc.Court of Appeals for the Third Circuit · 1989
- United States v. Article of Drug . . . Bacto-UnidiskSupreme Court of the United States · 1969
- United States v. Odessa Union Warehouse Co-Op Cecil A. Schell Edward Sewall Marvin KleynCourt of Appeals for the Ninth Circuit · 1987
- United States v. Nutri-Cology, Inc., D/B/A Allergy Research Group Biocurrents, Inc. Stephen A. Levine Susan D. LevineCourt of Appeals for the Ninth Circuit · 1992
16 more not listed; retrieve them via the Exa API.
3Cited by13 opinions
- Assisted Living Associates of Moorestown, L.L.C. v. Moorestown TownshipDistrict Court, D. New Jersey · 1998
- The Medicines Company v. Mylan, Inc.Court of Appeals for the Federal Circuit · 2017
- United States v. Universal Management Services, Inc., Corporation Natural Choice, Inc. Corporation, Doing Business as Natural Choice Products, Inc. Paul M. Monea, Individual Paul A. MoneaCourt of Appeals for the Sixth Circuit · 1999
- ReMed Recovery Care Centers v. Township of WillistownDistrict Court, E.D. Pennsylvania · 1999
- New Hampshire Department of Environmental Services v. MottoloSupreme Court of New Hampshire · 2007
8 more not listed; retrieve them via the Exa API.