Legal Opinion
DeVito v. Hem, Inc.
District Court, M.D. Pennsylvania
Decided March 6, 1989No. Civ. A. 88-1712Published
1Opinion of the Court
MEMORANDUM
RAMBO, District Judge.
Background
Defendants HEM, Inc. (HEM), and Du Pont, Inc. (Du Pont) are the “sponsors” of “clinical investigations” of an “investiga-tional new drug” called Ampligen. See 21 C.F.R. § 312.3(b) (1988). The clinical investigations were conducted at defendant Hah-nemann University's (Hahnemann) facilities. Defendant Food and Drug Administration (FDA) approved the clinical investigations of Ampligen under an Investiga-tional New Drug exemption (IND) from the requirements of the Federal Food, Drug and Cosmetic Act (the Act). See 21 U.S.C. § 355(i); 21 C.F.R. §§…
2Cases cited11 opinions
- Valley Forge Christian College v. Americans United for Separation of Church and State, Inc.Supreme Court of the United States · 1982
- Simon v. Eastern Kentucky Welfare Rights OrganizationSupreme Court of the United States · 1976
- Gladstone, Realtors v. Village of BellwoodSupreme Court of the United States · 1979
- United States v. RutherfordSupreme Court of the United States · 1979
- Ecri, a Nonprofit Pennsylvania Corporation v. McGraw Inc., McGraw Information Systems Co., and McGraw Book Co.Court of Appeals for the Third Circuit · 1987
6 more not listed; retrieve them via the Exa API.