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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Notice · Aug 1, 2011
If FDA authorizes a request for reconditioning, the reconditioning operations are carried out under the supervision of either FDA or U.S. … Payment must be made within 30 days of the invoice date in U.S. currency by check, bank draft, or U.S. postal money order payable to the order of the Food and Drug Administration.
76 FR 45820Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; IMAGENT
Federal Register · Notice · Apr 21, 2003
Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for IMAGENT (U.S. … In its application for patent extension, this applicant seeks 423 days of patent term extension.
68 FR 19546Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 1, 2012
The fee will be assessed for not complying with a recall order under section 423(d) or 412(f) of the FD&C Act to cover food recall activities associated with such order performed by the Secretary (and … Payment must be made within 90 days of the invoice date in U.S. currency by check, bank draft, or U.S. postal money order payable to the order of the Food and Drug Administration.
77 FR 45636Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 13, 1998
Of this time, 2,066 days occurred during the testing phase of the regulatory review period, while 423 days occurred during the approval phase. … However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension.
63 FR 54720Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 10, 2010
and 10/11-28 (ethinyl estradiol; norethindrone) Tablets, 0.035 mg, 0.035 mg; 0.5 mg, 1 mg Ortho McNeil Janssen Pharmaceuticals, Inc., 1125 Trenton Harbourton Rd., Titusville, NJ 08560 NDA 18-423 … Sponge, 4 % Molnycke Health Care, 5550 Peachtree Parkway, Ste. 500, Norcross, GA 30092 NDA 19-436 PRIMACOR (milrinone lactate) Injection, Equivalent to (EQ) 1 mg base/milliliter Sanofi Aventis U.S
75 FR 48352Health and Human Services DepartmentFood and Drug AdministrationDisqualification 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 AdministrationFederal Register · Notice · Feb 25, 2002
Of this time, 1,435 days occurred during the testing phase of the regulatory review period, while 482 days occurred during the approval phase. … However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension.
67 FR 8547Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 17, 2012
Murray and colleagues (Ref. 7) also conducted a large-scale survey of U.S. physicians regarding their perceptions of DTC advertising, but they also did not include nurse practitioners or physician assistants … Mullins, “The Development of Direct-to-Consumer Prescription Drug Advertising Regulations,” Food and Drug Law Journal, 57, 423-443, 2002. 3. Curry, T.J., J. Jarosch, and S.
77 FR 2299Health and Human Services DepartmentFood and Drug AdministrationArnold S. Mendell; Debarment Order
Federal Register · Uncategorized Document · Dec 21, 1994
Safley, 482 U.S. 78, 89 (1987) (regulations valid if reasonably related to legitimate governmental interests)). … No. 1546, 87th Cong., 2d sess. 8 (1962), U.S. Code Cong. & Admin.
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 25, 1997
synthetic) isophane suspension) NDA 19-482 5% Dextrose and 0.225% Sodium Chloride Abbott Laboratories. … AADA 62-387 Nystatin Cream USP, 100,000 Units/g Alpharma, U.S.
62 FR 50387Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; SEVENFACT
Federal Register · Notice · Nov 4, 2021
FDA has made the determination because of the submission of an application to the Director of the U.S. … In its application for patent extension, this applicant seeks 482 days of patent term extension. III.
86 FR 60827Health 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 AdministrationFederal Register · Notice · Nov 7, 2007
Genentech Inc., 1 DNA Way MS#242, South San Francisco, CA 94080-4990 ANDA 40-098 Acetaminophen and Codeine Phosphate Oral Solution USP Clonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc., U.S … ANDA 74-423 Captopril Tablets USP, 12.5 mg, 25 mg, 50 mg, and 100 mg Clonmel Healthcare, Ltd., c/o of STADA Pharmaceuticals Inc.
72 FR 62858Health 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 AdministrationFederal Register · Notice · May 5, 2004
NDA 50-439 Erythrocin (erythromycin stearate) Abbott Laboratories NDA 50-482 Keflin (cephalothin sodium) for Injection Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN … -8299 ANDA 70-917 Nalbuphine HCl Injection, 20 mg/mL Abbott Laboratories ANDA 72-639 Metoclopramide HCl Tablets USP, 10 mg Clonmel Healthcare Ltd., c/o STADA Pharmaceuticals Inc., U.S
69 FR 25124Health and Human Services DepartmentFood and Drug AdministrationDigoxin Products for Oral Use; Revocation of Conditions for Marketing
Federal Register · Rule · Jun 26, 2002
Shrewsbury Township , 808 F.2d 1023, 1031 (3d Cir.), cert. denied, 482 U.S. 906 (1987) (no taking even given reduction in value from $800,000 to $60,000); Village of Euclid v. … Cir. 1986), cert. denied 479 U.S. 1053 (1987); see also Andrus v. Allard , 444 U.S. 51, 66 (1979).)
67 FR 42992Health and Human Services DepartmentFood and Drug AdministrationJohn J. Ferrante et al; Withdrawal of Approval of 125 Abbreviated New Drug Applications
Federal Register · Notice · Feb 2, 2001
Bristol-Myers, U.S. Pharmaceutical Group, Evansville, IN 47721- 0001. 61-523 1 Tetracycline HCl Susceptibility Powder, 20 mg. … C & M Pharmacal, Inc., 1721 Maple Lane, Hazel Park, MI 48030-1215. 80-482 Hydrocortisone Cream USP. Do. 80-562 Prednisolone Tablets, 2.5 mg and 5 mg. John J.
66 FR 8801Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 5, 2019
Although FDA has no reason to believe that U.S. suppliers of glycerol and propylene glycol currently use DEG, FDA has detected DEG in e-liquids and ENDs aerosol (Refs. 15 and 16). 9 Therefore, the … IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Vol. 77, at 482 (2000). https://monographs.iarc.fr/wp-content/uploads/2018/06/mono77.pdf . *4. Borghardt, J.M., C.
84 FR 38032Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 28, 2000
Bristol-Myers, U.S. Pharmaceutical Group, Evansville, IN 47721-0001. 61-523 Tetracycline HCl Susceptibility Power, 20 mg. … C & M Pharmacal, Inc., 1721 Maple Lane, Hazel Park, MI 48030-1215. 80-482 Hydrocortisone Cream USP. Do. 80-562 Prednisolone Tablets, 2.5 mg and 5 mg. John J.
65 FR 16397Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 9, 1996
The sources of this information may include the U.S. military, health departments or physicians of former donors now found to be HIV-infected or diagnosed as having AIDS. … This rule will affect all of the 3,015 registered U.S. blood establishments.
61 FR 47413Health and Human Services DepartmentFood and Drug Administration
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