Documents
Briefs, oral arguments, agency decisions and the Federal Register.
83 results
0.51s
Biological Products: Reporting of Biological Product Deviations in Manufacturing
Federal Register · Rule · Nov 7, 2000
0.21 2.6 0 25 to 49 906 2.02 24.6 0 150 to 99 1,128 6.03 73.3 0 100 to 199 1,338 19.38 235.9 0 200 to 299 692 20.99 255.4 0 300 to 399 … (Comment 33) One comment to OMB and 24 comments submitted to the docket state that the estimated time of 0.5 hours to complete a deviation report is underestimated.
65 FR 66621Health and Human Services DepartmentFood and Drug AdministrationDissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices
Federal Register · Rule · Nov 20, 1998
The latter extension cannot exceed 24 months. … No. 399, 105th Cong., 1st sess. at 100 (1997); 143 Congressional Record S9,837 (daily ed. Sept. 24, 1997) (Statement of the Managers)).
63 FR 64556Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Feb 15, 1995
Stephenson, ``An Assessment of the Complications of the Brantley Scott Artificial Sphincter,'' British Journal of Urology, 60(2):119- 121, 1987. 24. Khoury, A. E., and B. M. … Retik, ``The Long-Term Results of Artificial Sphincters in Children,'' The Journal of Urology, 146(2):396-399, 1991. 99.
60 FR 8595Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 14, 1997
B. et al., ``Acetaminophen Hepatotoxicity in Alcoholics,'' Annals of Internal Medicine, 104:399-404, 1986. 27. Villeneuve, J. … S, ``Interaction of Alcohol and Drugs,'' Practical Gastroenterology, 7:23-24, 29-30, and 48, 1983. 43.
62 FR 61041Health and Human Services DepartmentFood and Drug AdministrationVaginal Contraceptive Drug Products for Over-the-Counter Human Use
Federal Register · Proposed Rule · Feb 3, 1995
J., ``Spermicide Use and Down's Syndrome,'' American Journal of Public Health, 72:399-401, 1982. 4. Citizen Petition, submitted by A. … Food and Drug Administration, ``General Guidelines for OTC Drug Combination Products, September 1978,'' Docket No. 78D-0322, Dockets Management Branch. 24.
60 FR 6892Proposed RuleHealth and Human Services DepartmentFood Labeling: Health Claims; Soluble Dietary Fiber From Certain Foods and Coronary Heart Disease
Federal Register · Rule · Oct 2, 2002
No. 105-399, at 98 (1997)). … Engstrom, “Intestinal Contents Supernatant Viscosity of Rats Fed Oat-Based Muffins and Cereal Products,” Cereal Chemistry , 76:21-24, 1999. 22. Gallaher, D.
67 FR 61773Health and Human Services DepartmentFood and Drug AdministrationAnnual Comprehensive List of Guidance Documents at the Food and Drug Administration
Federal Register · Notice · Mar 28, 2006
Standard for Laser Products; Guidance for Industry and FDA 1412 07/12/2002 (8) Guide for Preparing Abbreviated Reports of Microwave and RF Emitting Electronic Products Intended for Medical Use 399 … 2005 05/24/05 177.
71 FR 15422Health and Human Services DepartmentFood and Drug AdministrationUnique Device Identification System
Federal Register · Rule · Sep 24, 2013
(citing Sunshine Anthracite, 310 U.S. at 399, United States v. Frame, 885 F.2d 1119, 1129 (3d Cir. 1989), cert. denied, 493 U.S. 1094 (1990))). … PART 820—QUALITY SYSTEM REGULATION 24.
78 FR 58786Health and Human Services DepartmentFood and Drug AdministrationComprehensive List of Guidance Documents at the Food and Drug Administration
Federal Register · Notice · Aug 9, 2010
Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (PDF - 315 KB) Final 9/29/2004 PET Drug Products - Current Good Manufacturing Practice (CGMP) (PDF - 399 … Multiple Prescriptions (PDF - 114KB) Draft 1/11/2010 Guidance for Sponsors, Clinical Investigators, and IRBs; Data Retention When Subjects Withdraw From FDA-Regulated Clinical Trials (PDF - 399
75 FR 48180Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Oct 24, 2002
discussion of the replacement effect and of the relationship between research and social welfare can be found in Jean Tirole, The Theory of Industrial Organization (Cambridge: MIT Press, 1988), pp. 392, 399 … Based on other rules that require respondents to compile and submit information in their possession, we estimate the burden to be 24 hours per event.
67 FR 65448Health and Human Services DepartmentFood and Drug AdministrationPhibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing
Federal Register · Notice · Apr 12, 2016
hours after withdrawal of treatment and that unchanged carbadox “ha[d] disappeared from the liver after 24 hours” (Ref. 8). … CVM also determined from submitted studies that the carcinogenic parent drug was undetectable in liver at 24 hours (Id.).
81 FR 21559Health and Human Services DepartmentFood and Drug AdministrationAntimicrobial Animal Drug Sales and Distribution Reporting
Federal Register · Rule · May 11, 2016
L. 90-399), requires sponsors of approved or conditionally approved new animal drugs to establish and maintain records and make such reports of data relating to experience and other data or information … We estimate that the 20 sponsors with active applications will take 24 hours to complete the review and develop a compliance plan.
81 FR 29129Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims; Soluble Dietary Fiber From Certain Foods and Coronary Heart Disease
Federal Register · Rule · Dec 23, 2005
No. 105-399, at 98 (1997)). We are satisfied that each of the three criteria in section 403(r)(7)(A) of the act have been met in the petition submitted by the National Barley Foods Council. … Jacobs, et al., “Oat Products and Lipid Lowering; A Meta-Analysis,” Journal of the American Medical Association , 267(24):3317-25, June 24, 1992. 19.
70 FR 76150Health and Human Services DepartmentFood and Drug AdministrationRegulations Regarding “Intended Uses”
Federal Register · Rule · Aug 2, 2021
June 24, 2014) (see also Ref. 2); United States v. Livdahl, 459 F. Supp. 2d 1255, 1260 (S.D. Fla. 2005)). … Id. at 399.
86 FR 41383Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 29, 2003
(Ref. 24). … Oral hygiene was suspended for 24 hours.
68 FR 32232Health and Human Services DepartmentFood and Drug AdministrationAnnual Comprehensive List of Guidance Documents at the Food and Drug Administration
Federal Register · Notice · Oct 24, 2001
August 1, 1981 Do Do Requirements for Infrequent Plasmapheresis Donors August 27, 1982 Do Do Recommendations to Decrease the Risk of Transmitting AIDS From Plasma Donors March 24 … September 1, 1995 OC/DOEI&III Do 264 Guide for Preparing Abbreviated Reports of Microwave and RF Emitting Electronic Products Intended for Medical Use September 1, 1996 OC/DOEI&III Do 399
66 FR 53836Health and Human Services DepartmentFood and Drug AdministrationExpanded Access to Investigational Drugs for Treatment Use
Federal Register · Proposed Rule · Dec 14, 2006
individual with a life-threatening or seriously debilitating illness for which there is not an effective, approved therapy” (Joint Explanatory Statement of the Committee of Conference in House Report 105-399 … (24 hours x $100).
71 FR 75147Health and Human Services DepartmentFood and Drug AdministrationFinal Determination Regarding Partially Hydrogenated Oils
Federal Register · Notice · Jun 17, 2015
Honigfort, Literature Review, June 11, 2015. 24. Kiage J. N., P. D. Merrill, S. E. … C., “Dietary Fats and Coronary Heart Disease,” Journal of Internal Medicine, 272:13-24, 2012. 58.
80 FR 34650Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 17, 2013
Approximately 50 percent of the applied dose was absorbed at 24 hours after a single dose and approximately 65 percent at 24 hours after 14 and 28 days of daily dosing. … W., “90-Day Subchronic Dermal Toxicity Study in the Rat With Satellite Group With Irgasan DP 300 (MRD-92-399),” Comment No. C1 in Docket No. 1975N-0183H, 1994. 214. “Nomination Profile: Triclosan.
78 FR 76444Health and Human Services DepartmentFood and Drug AdministrationSurgeon's and Patient Examination Gloves; Reclassification
Federal Register · Proposed Rule · Jul 30, 1999
In the Federal Register of June 24, 1988 (53 FR 23856), FDA issued a final rule classifying the surgeon's glove into class I without exemptions. … Dawson, Rockville, MD, 1997. 24. McLelland, J., S. Shuster, and J.
64 FR 41710Health and Human Services DepartmentFood and Drug Administration
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