Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of a New Drug Application for IRESSA
Federal Register · Notice · Apr 25, 2012
, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and § 314.150(d), and under authority delegated by the Commissioner to the Director, Center for Drug Evaluation and Research, approval of NDA 21-399 … [FR Doc. 2012-9944 Filed 4-24-12; 8:45 am] BILLING CODE 4160-01-P
77 FR 24723Health and Human Services DepartmentFood and Drug AdministrationOncologic Drugs Advisory Committee; Notice of Meeting
Federal Register · Notice · Aug 27, 2002
Agenda : On September 24, 2002, the committee will discuss new drug application (NDA) 21-399, IRESSAr (gefitinib), AstraZeneca Pharmaceuticals LP, indicated for the treatment of patients with locally … Oral presentations from the public will be scheduled between approximately 8:45 a.m. and 9:45 a.m. on September 24, 2002. Time allotted for each presentation may be limited.
67 FR 55024Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 4, 2011
Pending PMCs comprise 50 percent (201/399) of the on-schedule NDA/ANDA PMCs and 28 percent (66/236) of the on-schedule BLA PMCs. … ) Combined total 399 (84%) 236 (77%) 1 See note 1 for table 1 of this document.
76 FR 47211Health and Human Services DepartmentFood and Drug AdministrationNew Animal Drugs; Change of Sponsor; Fentanyl; Iron Injection
Federal Register · Rule · Jul 24, 2013
DATES: This rule is effective July 24, 2013. FOR FURTHER INFORMATION CONTACT: Steven D. … Mowbray, Leicestershire, England LE13 0PB has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 099-667 for IMPOSIL (iron dextran complex) Injection and NADA 110-399
78 FR 44432Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; XOFLUZA
Federal Register · Notice · Aug 8, 2024
The date the application was approved: October 24, 2018. FDA has verified the applicant's claim that NDA 210854 was approved on October 24, 2018. … In its application for patent extension, this applicant seeks 399 days of patent term extension. III.
89 FR 64920Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 30, 2020
Food and Drug Administration, et al., 399 F.Supp.3d 479 (D. Md. 2019). … Dated: April 24, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020-09163 Filed 4-29-20; 8:45 am] BILLING CODE 4164-01-P
85 FR 23968Health and Human Services DepartmentFood and Drug AdministrationFederal 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 · Rule · Aug 28, 2000
That sentence reads: “Heating of the final containers of Albumin (Human) shall begin within 24 hours after completion of filling.” … American Journal of Epidemiology , 103:399-407, 1976. 2. Vox Sanguinis , 47:7-18, 1984. 3. Vox Sanguinis , 47:28-40, 1984. 4. Metabolism , 14:1311-1323, 1965. 5.
65 FR 52016Health and Human Services DepartmentFood and Drug AdministrationFederal 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 · 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 · 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 · 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 Administration
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