21 C.F.R. § 630.10 - General donor eligibility requirements
| Cite as | 21 C.F.R. § 630.10 |
| Currency | Current through December 7, 2020 |
-
- This document is available in original version only for vLex customers
View this document and try vLex for 7 days - TRY VLEX
- This document is available in original version only for vLex customers
18 practice notes
-
817 F.2d 560 (9th Cir. 1987), 86-5578, Baker v. United States
...Sec. 2680(a) (emphasis added). The plaintiff in this case alleges the negligent failure of HEW to require the mandatory tests of 21 C.F.R. Sec. 630.10(b) 3 Page 563 Lederle was licensed to manufacture live, oral poliovirus vaccine in 1963 for release to the public. Baker contends that the f......
-
661 F.2d 552 (6th Cir. 1981), 79-1725, Schindler v. United States
...of neurological illness has been demonstrated by blood tests (stool examinations and other appropriate methods, in violation of 21 CFR § 630.10(2)." [4] Because of the wording of 28 U.S.C. § 1346(b), supra, most courts consider the applicability of the discretionary function exception ......
-
774 F.Supp. 952 (D.Md. 1991), MDL 780, In re Sabin Oral Polio Vaccine Products Liability Litigation
...Drug Administration. I will also cite regulations from former volume 42 of the Code of Federal Regulations which currently appear at 21 C.F.R. §§ 630.10-630.17 [2] The plaintiff in Miller was exposed to shed virus from vaccine derived from seed 45 B 85, and the plaintiff in Musgrove was exp......
-
984 F.2d 124 (4th Cir. 1993), 91-2398, In re Sabin Oral Polio Vaccine Products Liability Litigation
...et seq.; the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301 et seq.; and regulations, 42 C.F.R. §§ 73.110-73.118 (recodified as 21 C.F.R. §§ 630.10-630.17 (1991)). For consistency with the district court, we will refer to the regulations as originally I In Sabin I, 743 F.Supp. 410, t......
Request a trial to view additional results
15 cases
-
817 F.2d 560 (9th Cir. 1987), 86-5578, Baker v. United States
...Sec. 2680(a) (emphasis added). The plaintiff in this case alleges the negligent failure of HEW to require the mandatory tests of 21 C.F.R. Sec. 630.10(b) 3 Page 563 Lederle was licensed to manufacture live, oral poliovirus vaccine in 1963 for release to the public. Baker contends that the f......
-
661 F.2d 552 (6th Cir. 1981), 79-1725, Schindler v. United States
...of neurological illness has been demonstrated by blood tests (stool examinations and other appropriate methods, in violation of 21 CFR § 630.10(2)." [4] Because of the wording of 28 U.S.C. § 1346(b), supra, most courts consider the applicability of the discretionary function exception ......
-
774 F.Supp. 952 (D.Md. 1991), MDL 780, In re Sabin Oral Polio Vaccine Products Liability Litigation
...Drug Administration. I will also cite regulations from former volume 42 of the Code of Federal Regulations which currently appear at 21 C.F.R. §§ 630.10-630.17 [2] The plaintiff in Miller was exposed to shed virus from vaccine derived from seed 45 B 85, and the plaintiff in Musgrove was exp......
-
984 F.2d 124 (4th Cir. 1993), 91-2398, In re Sabin Oral Polio Vaccine Products Liability Litigation
...et seq.; the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301 et seq.; and regulations, 42 C.F.R. §§ 73.110-73.118 (recodified as 21 C.F.R. §§ 630.10-630.17 (1991)). For consistency with the district court, we will refer to the regulations as originally I In Sabin I, 743 F.Supp. 410, t......
Request a trial to view additional results
3 provisions
-
Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry; Availability
...donors for ZIKV risk factors such as travel history and deferring them as previously recommended in the February 2016 guidance. Under 21 CFR 630.10(a), if a donor volunteers a recent history of ZIKV infection, a blood establishment must not collect blood or blood components from that donor.......
-
Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus; Guidance for Industry; Availability
...products from symptomatic individuals, if they were to donate, would have the potential of transmitting Ebola virus to recipients. Under 21 CFR 630.10(a) and (f)(1), a donor must be in good health and have a normal temperature at the time of donation. Standard procedures that are in place t......
-
Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use-Compliance Policy; Guidance for Industry; Availability
...(i.e., not subject to cross-over). Specifically, the guidance describes FDA's policy with respect to the following: The requirements in 21 CFR 630.10 related to screening autologous donors for relevant transmitted infections; the requirement in 21 CFR 630.15(a)(1)(ii) that the responsible p......