21 C.F.R. § 14.100 - List of standing advisory committees
| Cite as | 21 C.F.R. § 14.100 |
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68 practice notes
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In re Medimmune, Inc. Securities Litigation, No. PJM 93-3980.
...by a team of FDA personnel and, in significant instances, forwarded to an advisory committee of outside experts. See 21 C.F.R. §§ 14.1, 14.100(b)(3). The committee reviews the data and ultimately recommends to the FDA whether the PLA should be approved and for what uses. Respivir proceeded ......
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Organization, functions, and authority delegations:
Biological Response Modifiers Advisory Committee; name change to Cellular, Tissue and Gene Therapies Advisory Committee and function change,
...Online via GPO Access [wais.access.gpo.gov] [DOCID:fr28oc04-6] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 14 Advisory Committee: Change of Name and Function; Technical AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. S......
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Advisory Committee; Pharmacy Compounding Advisory Committee
...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 14 Docket No. Advisory Committee; Pharmacy Compounding Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ----------------------------------------------------------------------- S......
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Advisory Committee; Food Advisory Committee; Termination
...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 14 Docket No. Advisory Committee; Food Advisory Committee; Termination AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMM......
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1 cases
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873 F.Supp. 953 (D.Md. 1995), PJM 93-3980, In re Medimmune, Inc. Securities Litigation
...by a team of FDA personnel and, in significant instances, forwarded to an advisory committee of outside experts. See 21 C.F.R. §§ 14.1, 14.100(b)(3). The committee reviews the data and ultimately recommends to the FDA whether the PLA should be approved and for what uses. Respivir proceeded ......
1 firm's commentaries
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Do Compounding Pharmacies 'Live In Sin'? The FDA's Assertion Of Enforcement Authority Over Pharmacy Compounding, And Two Courts' Efforts To Bless The Practice
...Western States Medical Center v. Shalala, 238 F.3d 1090 (9th Cir. 2001). 21 C.F.R. §§ 14.100(c)(18), 216.24. 12. This language is taken from a warning letter that is highlighted on the FDA's web site. The FDA took a similar position before the Fifth Circuit while litigating Medical Center U......
66 provisions
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Organization, functions, and authority delegations:
Biological Response Modifiers Advisory Committee; name change to Cellular, Tissue and Gene Therapies Advisory Committee and function change,
...Online via GPO Access [wais.access.gpo.gov] [DOCID:fr28oc04-6] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 14 Advisory Committee: Change of Name and Function; Technical AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. S......
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Advisory Committee; Pharmacy Compounding Advisory Committee
...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 14 Docket No. Advisory Committee; Pharmacy Compounding Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ----------------------------------------------------------------------- S......
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Advisory Committee; Food Advisory Committee; Termination
...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 14 Docket No. Advisory Committee; Food Advisory Committee; Termination AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMM......
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Advisory committees:
Risk Communication Advisory Committee; establishment,
...the name of the Risk Communication Advisory Committee, already established by charter, to the list of standing advisory committees in 21 CFR 14.100. Therefore, the agency is amending 21 CFR 14.100(a) as set forth below. List of Subjects in 21 CFR Part 14 Administrative practice and procedur......
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