21 C.F.R. §207.69 - What are the requirements for an official contact and a United States agent?
| Cite as | 21 C.F.R. §207.69 |
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1 cases
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In re Valsartan, Losartan, & Irbesartan Prods. Liab. Litig., MDL No. 2875 (RBK-KMW)
...of these respective manufacturers Zhejiang Huahai Pharmaceuticals, Ltd., Aurobindo India Ltd., and Hetero India, is an agent under 21 C.F.R. § 207.69(b)3 by which the FDA can always have a U.S. "communications" contact between it and the foreign manufacturers. ECF Doc. 520-3: 57-58. The mfr......
2 firm's commentaries
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A Word To The Wise Locate Your FDA-Mandated Agents With Care
...to the United States for purposes of importation. . . . 21 U.S.C. §360(i) (emphasis added). The corresponding FDA regulations are 21 C.F.R. §207.69(b) (for drugs), and 21 C.F.R. §803.58(a) (for Our advice is that, overseas manufacturers (and others required to register) ought to consider th......
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A Word To The Wise – Locate Your FDA-Mandated Agents With Care
...to the United States for purposes of importation. . . . 21 U.S.C. §360(i) (emphasis added). The corresponding FDA regulations are 21 C.F.R. §207.69(b) (for drugs), and 21 C.F.R. §803.58(a) (for devices). Our advice is that, overseas manufacturers (and others required to register) ought to c......