Documents
Briefs, oral arguments, agency decisions and the Federal Register.
254 results
0.18s
Federal Register · Rule · Feb 24, 2017
DATES: This rule is effective February 24, 2017, except for the amendment to 21 CFR 524.1465, which is effective March 6, 2017. FOR FURTHER INFORMATION CONTACT: George K. … Product name 21 CFR section 099-667 IMPOSIL (iron heptomer) Injection 522.1182 110-399 GLEPTOSIL (gleptoferron) Injection 522.1055 Following these changes of sponsorship, Sogeval
82 FR 11506Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 31, 2009
Ltd., having a place of business at Level 5, Building 4, 399 Royal Parade, Parkville, Victoria 3052, Australia, a wholly-owned subsidiary of Arana Therapeutics Limited, having a place of business at Level … Dated: August 24, 2009. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc.
74 FR 44862Health and Human Services DepartmentNational Institutes of HealthFederal Register · Notice · Jul 15, 2020
Sripa, et al., 2012, “Trematode Infections: Liver and Lung Flukes,” Infectious Disease Clinics of North America, 26(2):399-419. 14. Qian, M.-B., Y.-D. Chen, S. … *WHO, 2018, “Neglected Tropical Diseases,” accessed October 24, 2019, https://www.who.int/neglected_diseases/diseases/en/. 18.
85 FR 42868Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Mar 17, 2014
L. 90-399). … established that public disclosure by the Agency of certain data and information in an NADA file could not occur before the Federal Register notice of approval published (39 FR 44653, December 24
79 FR 14630Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Aug 29, 2016
Broomhill Rd., Tallaght, Dublin 24, Ireland FERROFORTE (gleptoferron injection) Piglets Original approval as a generic copy of NADA 110-399 FOI Summary. 1 The Agency has carefully considered … In the “Sponsor” column, numerically add “016952”. 24.
81 FR 59131Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 17, 2014
L. 90-399). … revision established that public disclosure by the Agency of certain data and information in an NADA file could not occur before the Federal Register notice of approval published (39 FR 44653, December 24
79 FR 14609Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 19, 2026
and replaced with newer version. 8-399 8-630 ASTM F90-24 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605) Withdrawn … version. 11-325 11-430 ASTM F564-24 Standard Specification and Test Methods for Metallic Bone Staples Withdrawn and replaced with newer version. 11-326 11-431 ASTM F384-24 Standard
91 FR 7994Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 15, 2020
One study reported 16 cases of paragonimiasis acquired in Missouri from 2008 to 2014, which were associated with consumption of raw crayfish (Ref. 24). … Sripa, et al., 2012, “Trematode Infections: Liver and Lung Flukes,” Infectious Disease Clinics of North America, 26(2):399-419. 11. Qian, M-B., Y-D. Chen, S.
85 FR 42883Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 19, 2012
NDA 050687 Banan (cefpodoxime proxetil) Tablets, 100 mg and 200 mg Daiichi Sankyo, Inc., 399 Thornall St., 11th Floor, Edison, NJ 08837. … ANDA 089208 Methylprednisolone Tablets USP, 24 mg Do. ANDA 089209 Methylprednisolone Tablets USP, 32 mg Do.
77 FR 16039Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 3, 2005
The technical amendment to the interim final rule published at 69 FR 29428 was effective May 24, 2004. … Based on the requirements in the proposed rule, the lowest fee quoted was $399 for representation by a U.S. agent for 1 year; other U.S. agents charged initial fees between $599 and $1,400.
70 FR 57505Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 27, 2024
Dosages higher than [equivalent 24 mg buprenorphine OR 24 mg/6 mg buprenorphine/naloxone] have not been demonstrated to provide any clinical advantage. … Martin, CE, C Shadowen, B Thakkar, et al., 2020, “Buprenorphine Dosing for the Treatment of Opioid Use Disorder Through Pregnancy and Postpartum,” Curr Treat Options Psychiatry, 7(3): 375-399.
89 FR 105613Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 22, 1998
Nutrition (quarterly reports of selected research projects, 1st quarter 1995) issued by the USDA's ARS and provided on the Internet (``http://www.ars.usda.gov/is/ qtr/q195/hn195.htm'' accessed on 12/24 … Rept. 105-399, at 98 (1997)).
63 FR 34112Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 14, 2003
Wiita, “Androgen and Estrogen-Androgen Hormone Replacement Therapy: A Review of the Safety Literature, 1941 to 1996,” Clinical Therapeutics , 19(3):383-399, 1997. 6. … Morris, “Menopausal Symptoms,” Clinical Evidence , 5: 1308-1310, June 2001. 24. Rosenberg, M. J., T. D. N. King, and M. C.
68 FR 17953Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Aug 4, 2009
ICRP (1994), “Human respiratory tract model for radiological protection,” (Ann Int Comm Rad Protect, Vol. 24). 21. … FDA-2008-N-0163; July 24, 2008. 83.
74 FR 38686Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 8, 2003
Under section 108(b)(2) of Public Law 90-399 (82 Stat. 353), the Animal Drug Amendments of 1968, any approval of a new animal drug granted prior to the law's effective date, whether through approval of … Treatment should continue 24 to 48 hours beyond remission of disease symptoms.
68 FR 47332Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 27, 2012
Willis, “A Review of European Research on Consumer Response to Nutrition Information on Food Labels,” Journal of Public Health, vol. 15, pp. 384-399, 2007. 11. Kellogg Company. … [FR Doc. 2012-4423 Filed 2-24-12; 8:45 am] BILLING CODE 4160-01-P
77 FR 11547Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 24, 2026
These modifications to the list of recognized standards are applicable August 24, 2026. … 397 Dentistry—Test methods for machining accuracy of computer-aided milling machines ISO 23298 First edition 2023-05. 4-398 Dentistry—Excavators ISO 23940 First edition 2021-04. 4-399
91 FR 54715Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 3, 1995
l Provider Services. 399 <bu Quarterly Periodic Interim Payment Report. … MB-008-FC Medicaid Program; Home and Community-Based 09/23/94 08/24/94 Services and Respiratory
60 FR 132Health and Human Services DepartmentFederal Register · Notice · Sep 12, 1997
85.06 1.19 49,945,361 Louisiana................................ 194 0.8934 173.31 2.42 101,762,991 Maine.................................... 24 … 150.62 2.10 88,440,626 New Mexico............................... 107 0.9169 98.11 1.37 57,605,226 New York................................. 399
62 FR 48098Health and Human Services DepartmentHealth Care Finance AdministrationGastroenterology-Urology Devices: Reclassification of the Penile Rigidity Implant
Federal Register · Proposed Rule · Dec 16, 1997
Ludlow, ``Management of Infected Penile Implants,'' Techniques in Urology, 1(3):115-119, 1995. 24. Mulcahy, J. J., R. J. Krane, L. K. Lloyd, M. Edson, and M. B. … Carson, ``Patient Satisfaction in Scott and Small--Carrion Penile Implant Recipients: A Study of 52 Patients,'' Archives of Sexual Behavior, 15(5):393- 399, 1986. 35. Steidle, C. P., and J. J.
62 FR 65770Health and Human Services DepartmentFood and Drug Administration
Ask Donna what matters in the record.
She can read the source against your case and show you exactly where the answer came from.