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The Food and Drug Administration and its problems.

The New England journal of medicine

Raubicheck CJ.
PMID: 1727074
N Engl J Med. 1992 Jan 02;326(1):70; author reply 70-1.

No abstract available.

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Raubicheck CJ. The Food and Drug Administration and its problems. N Engl J Med. 1992;326(1):70; author reply 70-1
Raubicheck, C. J. (1992). The Food and Drug Administration and its problems. The New England journal of medicine, 326(1), 70; author reply 70-1.
Raubicheck, C J. "The Food and Drug Administration and its problems." The New England journal of medicine vol. 326,1 (1992): 70; author reply 70-1.
Raubicheck CJ. The Food and Drug Administration and its problems. N Engl J Med. 1992 Jan 02;326(1):70; author reply 70-1. PMID: 1727074.
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Remarks by the Commissioner. FDA.

Journal of parenteral science and technology : a publication of the Parenteral Drug Association

Kessler DA.
PMID: 1886036
J Parenter Sci Technol. 1991 May-Jun;45(3):118-21.

No abstract available.

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Kessler DA. Remarks by the Commissioner. FDA. J Parenter Sci Technol. 1991;45(3):118-21
Kessler, D. A. (1991). Remarks by the Commissioner. FDA. Journal of parenteral science and technology : a publication of the Parenteral Drug Association, 45(3), 118-21.
Kessler, D A. "Remarks by the Commissioner. FDA." Journal of parenteral science and technology : a publication of the Parenteral Drug Association vol. 45,3 (1991): 118-21.
Kessler DA. Remarks by the Commissioner. FDA. J Parenter Sci Technol. 1991 May-Jun;45(3):118-21. PMID: 1886036.
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Regulations, proposals, guidelines, advisory opinions, and letters of advice: what legal significance?.

Journal of parenteral science and technology : a publication of the Parenteral Drug Association

Horton LR.
PMID: 1886041
J Parenter Sci Technol. 1991 May-Jun;45(3):138-41.

No abstract available.

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Horton LR. Regulations, proposals, guidelines, advisory opinions, and letters of advice: what legal significance?. J Parenter Sci Technol. 1991;45(3):138-41
Horton, L. R. (1991). Regulations, proposals, guidelines, advisory opinions, and letters of advice: what legal significance?. Journal of parenteral science and technology : a publication of the Parenteral Drug Association, 45(3), 138-41.
Horton, L R. "Regulations, proposals, guidelines, advisory opinions, and letters of advice: what legal significance?." Journal of parenteral science and technology : a publication of the Parenteral Drug Association vol. 45,3 (1991): 138-41.
Horton LR. Regulations, proposals, guidelines, advisory opinions, and letters of advice: what legal significance?. J Parenter Sci Technol. 1991 May-Jun;45(3):138-41. PMID: 1886041.
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Delegations of authority and organization; Center for Devices and Radiological Health. Food and Drug Administration, HHS. Final rule.

Federal register

[No authors listed]
PMID: 10557613
Fed Regist. 1999 Feb 02;64(21):4964-5.

The Food and Drug Administration (FDA) is amending the regulations for delegations of authority to reflect redelegations to other officials within the Center for Devices and Radiological Health (CDRH) pertaining to: Certifying true copies and using the Department seal,...

Cite
Delegations of authority and organization; Center for Devices and Radiological Health. Food and Drug Administration, HHS. Final rule. Fed Regist. 1999;64(21):4964-5
(1999). Delegations of authority and organization; Center for Devices and Radiological Health. Food and Drug Administration, HHS. Final rule. Federal register, 64(21), 4964-5.
"Delegations of authority and organization; Center for Devices and Radiological Health. Food and Drug Administration, HHS. Final rule." Federal register vol. 64,21 (1999): 4964-5.
Delegations of authority and organization; Center for Devices and Radiological Health. Food and Drug Administration, HHS. Final rule. Fed Regist. 1999 Feb 02;64(21):4964-5. PMID: 10557613.
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Summary of remarks: Orrin G. Hatch, U.S. Senate.

Food and drug law journal

[No authors listed]
PMID: 12436985
Food Drug Law J. 2002;57(2):229-30.

No abstract available.

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Summary of remarks: Orrin G. Hatch, U.S. Senate. Food Drug Law J. 2002;57(2):229-30
(2002). Summary of remarks: Orrin G. Hatch, U.S. Senate. Food and drug law journal, 57(2), 229-30.
"Summary of remarks: Orrin G. Hatch, U.S. Senate." Food and drug law journal vol. 57,2 (2002): 229-30.
Summary of remarks: Orrin G. Hatch, U.S. Senate. Food Drug Law J. 2002;57(2):229-30. PMID: 12436985.
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FDA: status quo or changes needed?.

Science (New York, N.Y.)

Nightingale SD.
PMID: 12610281
Science. 2003 Feb 28;299(5611):1315-7; author reply 1315-7. doi: 10.1126/science.299.5611.1315b.

No abstract available.

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Nightingale SD. FDA: status quo or changes needed?. Science. 2003;299(5611):1315-7; author reply 1315-7doi: 10.1126/science.299.5611.1315b.
Nightingale, S. D. (2003). FDA: status quo or changes needed?. Science (New York, N.Y.), 299(5611), 1315-7; author reply 1315-7. https://doi.org/10.1126/science.299.5611.1315b
Nightingale, Stephen D. "FDA: status quo or changes needed?." Science (New York, N.Y.) vol. 299,5611 (2003): 1315-7; author reply 1315-7. doi: https://doi.org/10.1126/science.299.5611.1315b
Nightingale SD. FDA: status quo or changes needed?. Science. 2003 Feb 28;299(5611):1315-7; author reply 1315-7. doi: 10.1126/science.299.5611.1315b. PMID: 12610281.
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FDA's role in responding to drug shortages.

American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists

Jensen V, Kimzey LM, Goldberger MJ.
PMID: 12166041
Am J Health Syst Pharm. 2002 Aug 01;59(15):1423-5. doi: 10.1093/ajhp/59.15.1423.

No abstract available.

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Jensen V, Kimzey LM, Goldberger MJ. FDA's role in responding to drug shortages. Am J Health Syst Pharm. 2002;59(15):1423-5doi: 10.1093/ajhp/59.15.1423.
Jensen, V., Kimzey, L. M., & Goldberger, M. J. (2002). FDA's role in responding to drug shortages. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 59(15), 1423-5. https://doi.org/10.1093/ajhp/59.15.1423
Jensen, Valerie, et al. "FDA's role in responding to drug shortages." American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists vol. 59,15 (2002): 1423-5. doi: https://doi.org/10.1093/ajhp/59.15.1423
Jensen V, Kimzey LM, Goldberger MJ. FDA's role in responding to drug shortages. Am J Health Syst Pharm. 2002 Aug 01;59(15):1423-5. doi: 10.1093/ajhp/59.15.1423. PMID: 12166041.
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Outsourcing challenges FDA to strengthen oversight abroad.

Nature medicine

Torres C.
PMID: 20134448
Nat Med. 2010 Feb;16(2):139. doi: 10.1038/nm0210-139a.

No abstract available.

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Torres C. Outsourcing challenges FDA to strengthen oversight abroad. Nat Med. 2010;16(2):139doi: 10.1038/nm0210-139a.
Torres, C. (2010). Outsourcing challenges FDA to strengthen oversight abroad. Nature medicine, 16(2), 139. https://doi.org/10.1038/nm0210-139a
Torres, Christian. "Outsourcing challenges FDA to strengthen oversight abroad." Nature medicine vol. 16,2 (2010): 139. doi: https://doi.org/10.1038/nm0210-139a
Torres C. Outsourcing challenges FDA to strengthen oversight abroad. Nat Med. 2010 Feb;16(2):139. doi: 10.1038/nm0210-139a. PMID: 20134448.
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FDA initiative may crack wall of secrecy.

Nature medicine

Schubert C.
PMID: 20208488
Nat Med. 2010 Mar;16(3):244. doi: 10.1038/nm0310-244.

No abstract available.

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Schubert C. FDA initiative may crack wall of secrecy. Nat Med. 2010;16(3):244doi: 10.1038/nm0310-244.
Schubert, C. (2010). FDA initiative may crack wall of secrecy. Nature medicine, 16(3), 244. https://doi.org/10.1038/nm0310-244
Schubert, Charlotte. "FDA initiative may crack wall of secrecy." Nature medicine vol. 16,3 (2010): 244. doi: https://doi.org/10.1038/nm0310-244
Schubert C. FDA initiative may crack wall of secrecy. Nat Med. 2010 Mar;16(3):244. doi: 10.1038/nm0310-244. PMID: 20208488.
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Advisory committee; Risk Communication Advisory Committee; establishment. Final Rule.

Federal register

[No authors listed]
PMID: 17674496
Fed Regist. 2007 Jul 27;72(144):41221-2.

The Food and Drug Administration (FDA) is announcing the establishment of the Risk Communication Advisory Committee in the Office of Planning, Office of the Commissioner. This document adds the Risk Communication Advisory Committee to the agency's list of standing...

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Advisory committee; Risk Communication Advisory Committee; establishment. Final Rule. Fed Regist. 2007;72(144):41221-2
(2007). Advisory committee; Risk Communication Advisory Committee; establishment. Final Rule. Federal register, 72(144), 41221-2.
"Advisory committee; Risk Communication Advisory Committee; establishment. Final Rule." Federal register vol. 72,144 (2007): 41221-2.
Advisory committee; Risk Communication Advisory Committee; establishment. Final Rule. Fed Regist. 2007 Jul 27;72(144):41221-2. PMID: 17674496.
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Acceleration of drug development: a collaboration of many stakeholders.

Clinical pharmacology and therapeutics

Reynolds KS.
PMID: 23689207
Clin Pharmacol Ther. 2013 Jun;93(6):455-9. doi: 10.1038/clpt.2013.63.

Modern drugs are used to treat and prevent diseases that previously led to morbidity and mortality. There is a high cost to this achievement--investment for each successful drug can exceed $1.8 billion. Late-phase drug candidate failure decreases efficiency of...

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Reynolds KS. Acceleration of drug development: a collaboration of many stakeholders. Clin Pharmacol Ther. 2013;93(6):455-9doi: 10.1038/clpt.2013.63.
Reynolds, K. S. (2013). Acceleration of drug development: a collaboration of many stakeholders. Clinical pharmacology and therapeutics, 93(6), 455-9. https://doi.org/10.1038/clpt.2013.63
Reynolds, K S. "Acceleration of drug development: a collaboration of many stakeholders." Clinical pharmacology and therapeutics vol. 93,6 (2013): 455-9. doi: https://doi.org/10.1038/clpt.2013.63
Reynolds KS. Acceleration of drug development: a collaboration of many stakeholders. Clin Pharmacol Ther. 2013 Jun;93(6):455-9. doi: 10.1038/clpt.2013.63. PMID: 23689207.
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Administrative practices and procedures; promulgation of regulations for the efficient enforcement of law--FDA. Final rule.

Federal register

[No authors listed]
PMID: 10111150
Fed Regist. 1991 Apr 04;56(65):13757-8.

The Food and Drug Administration (FDA) is amending its regulation governing notice-and-comment (informal) rulemaking by removing from the regulation the requirement that the agency issue interpretative rules and rules of agency practice and procedure by informal rulemaking. As amended,...

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Administrative practices and procedures; promulgation of regulations for the efficient enforcement of law--FDA. Final rule. Fed Regist. 1991;56(65):13757-8
(1991). Administrative practices and procedures; promulgation of regulations for the efficient enforcement of law--FDA. Final rule. Federal register, 56(65), 13757-8.
"Administrative practices and procedures; promulgation of regulations for the efficient enforcement of law--FDA. Final rule." Federal register vol. 56,65 (1991): 13757-8.
Administrative practices and procedures; promulgation of regulations for the efficient enforcement of law--FDA. Final rule. Fed Regist. 1991 Apr 04;56(65):13757-8. PMID: 10111150.
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Showing 1 to 12 of 107 entries