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Briefs, oral arguments, agency decisions and the Federal Register.
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Disqualification of a Clinical Investigator
Federal Register · Proposed Rule · Apr 13, 2011
Family Publications Service, Inc., 411 U.S. 356 (1973), and National Petroleum Refiners Association v. FTC, 482 F.2d 672 (DC Cir. 1973). See also Weinberger v. … Hynson, Westcott & Dunning, Inc., 412 U.S. 609 (1973); National Nutritional Foods Association v. Weinberger, 512 F.2d 688, cert denied, 423 U.S. 827 (1975); United States v.
76 FR 20575Health and Human Services DepartmentFood and Drug AdministrationLatex-containing Devices; User Labeling
Federal Register · Proposed Rule · Jun 24, 1996
Hynson, Westcott & Dunning, Inc., 412 U.S. 609 (1973); see also Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 653 (1973); National Ass'n of Pharmaceutical Manufacturers v. … Weinberger, 512 F.2d 688 (2d Cir.), cert. denied, 423 U.S. 825 (1975).)
61 FR 32618Health and Human Services DepartmentFood and Drug AdministrationLatex Condoms; User Labeling; Expiration Dating
Federal Register · Proposed Rule · May 24, 1996
Hynson, Westcott & Dunning, Inc., 412 U.S. 609 (1973); see also Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 653 (1973); National Ass'n of Pharmaceutical Manufacturers v. … Weinberger, 512 F.2d 688 (2d Cir.) cert. denied, 423 U.S. 825 (1975).
61 FR 26140Health and Human Services DepartmentFood and Drug AdministrationMicrobiology Devices; Classification of In Vitro Diagnostic Device for Bacillus Species Detection
Federal Register · Proposed Rule · May 18, 2011
Lohr 518 U.S. 470 (1996); Riegel v. Medtronic, 552 U.S. 312 (2008). … et al., “Phage isolated from lysogenic Bacillus anthracis,” vol. 85, Journal of Bacteriology, p. 423, 1963.
76 FR 28689Health and Human Services DepartmentFood and Drug AdministrationRadiology Devices; Reclassification of Medical Image Analyzers
Federal Register · Proposed Rule · Jun 4, 2018
FDA, 766 F.2d 592 (DC Cir.1985), cert. denied, 474 U.S. 1062 (1986)). FDA relies upon “valid scientific evidence” in the classification process to determine the level of regulation for devices. … Ferré, et al., “Computed-Aided Diagnosis (CAD) in the Detection of Breast Cancer,” European Journal of Radiology, 82(3): 417-423 (2013). 6. Fenton, J.J., G. Xing, J.G.
83 FR 25598Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 9, 2003
Division of Compliance Policy, Office of Enforcement, Office of Regulatory Affairs, U.S. Food and Drug Administration, U.S. … Bureau of Economic Analysis, U.S. Department of Commerce, U.S. International Transactions Accounts Data, table 2, U.S.
68 FR 25242Health and Human Services DepartmentFood and Drug AdministrationAmendments to Registration of Food Facilities
Federal Register · Proposed Rule · Apr 9, 2015
FSMA also created section 423 of the FD&C Act (21 U.S.C. 350 l ), which provides a “responsible party” an opportunity to voluntarily cease distribution and recall a food under specified circumstances … functions, with the passage of FSMA and FDAAA, food facility registration now also serves to determine the applicability of provisions in other sections of the FD&C Act, including sections 417, 418, 421, 423
80 FR 19160Health and Human Services DepartmentFood and Drug AdministrationGeneral and Plastic Surgery Devices; Reclassification of Certain Surgical Staplers
Federal Register · Proposed Rule · Apr 24, 2019
Cir.1985), cert. denied, 474 U.S. 1062 (1986)). FDA relies upon “valid scientific evidence” in the classification process to determine the level of regulation for devices. … associated with use error, a prospective, single-arm study evaluating use of a surgical stapler in gastrointestinal stapling applications found that 3.5 percent of stapler deployments in the study (15 of 423
84 FR 17116Health and Human Services DepartmentFood and Drug AdministrationRequired Warnings for Cigarette Packages and Advertisements
Federal Register · Proposed Rule · Nov 12, 2010
at p. 423). … at pp. 423, 508-509).
75 FR 69524Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 25, 2016
FDA also received a comment from the U.S. … Lohr, 518 U.S. 470 (1996); and Riegel v. Medtronic, 128 S. Ct. 999 (2008)).
81 FR 24386Health and Human Services DepartmentFood and Drug AdministrationLaboratory Accreditation for Analyses of Foods
Federal Register · Proposed Rule · Nov 4, 2019
U.S. … In the domestic context, the U.S.
84 FR 59452Health and Human Services DepartmentFood and Drug AdministrationUse of Ozone-Depleting Substances; Removal of Essential-Use Designations
Federal Register · Proposed Rule · Jun 11, 2007
Since 1978, the U.S. … Current U.S.
72 FR 32030Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 18, 2001
denied , 423 U.S. 827 (1975). … U.S.
66 FR 4688Health and Human Services DepartmentFood and Drug AdministrationSurgeon's and Patient Examination Gloves; Reclassification
Federal Register · Proposed Rule · Jul 30, 1999
Weinberger, 512 F.2d 688 (2d Cir.), cert. denied, 423 U.S. 825 (1975).) … U.S. Department of Commerce, U.S. Industrial Outlook, 1994. 42. Katz, M. L., and H. Rosen, Microeconomics, 2d Ed., Irwin Press, 1998. 43. U.S.
64 FR 41710Health and Human Services DepartmentFood and Drug AdministrationVaginal Contraceptive Drug Products for Over-the-Counter Human Use
Federal Register · Proposed Rule · Feb 3, 1995
Kreiss, J. et al., ``Efficacy of Nonoxynol 9 Contraceptive Sponge Use in Preventing Heterosexual Acquisition of HIV in Nairobi Prostitutes,'' Journal of the American Medical Association, 268(4):477-482 … United States, 244 F.2d 34 (10th Cir.), cert. denied, 354 U.S. 923 (1957).
60 FR 6892Proposed RuleHealth and Human Services DepartmentFederal Register · Proposed Rule · Jan 16, 2025
The U.S. … , the U.S.
90 FR 5032Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Nutrient Content Claims; Definition of Term “Healthy”
Federal Register · Proposed Rule · Sep 29, 2022
We used the “Healthy U.S. … While the Healthy U.S.
87 FR 59168Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jun 30, 2016
Kolpin, D.W. et al., “Pharmaceuticals, Hormones, and Other Organic Wastewater Contaminants in U.S. … Available at http://www.springer.com/medicine/surgery/journal/423. 140. Turner, P., B. Saeed, and M.C.
81 FR 42912Health and Human Services DepartmentFood and Drug AdministrationTobacco Products; Required Warnings for Cigarette Packages and Advertisements
Federal Register · Proposed Rule · Aug 16, 2019
U.S., at 530-31. … Heart, 100(5):414-423, 2014. Available at https://doi.org/10.1136/heartjnl-2013-304082. 27. Gades, N.M., A. Nehra, D.J. Jacobson, et al.
84 FR 42754Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 30, 2023
U.S United States. WHO World Health Organization. III. … Human skin wounds pose substantial risks to patients and increasing challenges to the U.S. public health (Ref. 5).
88 FR 83774Health and Human Services DepartmentFood and Drug Administration
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