21 C.F.R. §610.60 - Container label
| Cite as | 21 C.F.R. §610.60 |
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3 cases
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Mazur v. Merck & Co., Inc., Civ. A. No. 85-6494.
...expiration date, the storage directions, the indications and contraindications of vaccine usage, and the potential adverse reactions. 21 C.F.R. §§ 610.60-610.65. The language of the label and package circular is subject to FDA scrutiny and cannot be changed without FDA authorization. 21 C.F......
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Graham v. Wyeth Laboratories, 85-1481-K.
...is indicated and contraindicated; and (4) the product's potential adverse reactions which have been associated with the product's use. 21 C.F.R. §§ 610.60-610.65. The language used is subject to FDA approval, 21 C.F.R. §§ 1, 201; 50 Fed.Reg. 51108 (1985), and, once approved, the language ca......
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Jones By Jones v. Lederle Laboratories, 85 CV 949.
...and toxicity are prescribed. See id. §§ 620.4, .5. Finally, the general labeling requirements for biological drugs are set forth at 21 C.F.R. §§ 610.60-.65. As of June 1979, the Lederle DTP vaccine Tri-Immunol satisfied all of the relevant requirements, and was licensed by the FDA. The vacc......