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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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HIV testing updates and challenges: when regulatory caution and public health imperatives collide.

Current HIV/AIDS reports

Branson BM.
PMID: 25656347
Curr HIV/AIDS Rep. 2015 Mar;12(1):117-26. doi: 10.1007/s11904-014-0251-7.

Numerous improvements in HIV testing technology led recently to the first revision of recommendations for diagnostic laboratory testing in the USA in 25 years. Developments in HIV testing continue to produce tests that identify HIV infection earlier with faster...

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Branson BM. HIV testing updates and challenges: when regulatory caution and public health imperatives collide. Curr HIV/AIDS Rep. 2015;12(1):117-26doi: 10.1007/s11904-014-0251-7.
Branson, B. M. (2015). HIV testing updates and challenges: when regulatory caution and public health imperatives collide. Current HIV/AIDS reports, 12(1), 117-26. https://doi.org/10.1007/s11904-014-0251-7
Branson, Bernard M. "HIV testing updates and challenges: when regulatory caution and public health imperatives collide." Current HIV/AIDS reports vol. 12,1 (2015): 117-26. doi: https://doi.org/10.1007/s11904-014-0251-7
Branson BM. HIV testing updates and challenges: when regulatory caution and public health imperatives collide. Curr HIV/AIDS Rep. 2015 Mar;12(1):117-26. doi: 10.1007/s11904-014-0251-7. PMID: 25656347.
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New law aims to distance the FDA from the drug industry.

BMJ (Clinical research ed.)

Lenzer J.
PMID: 15891225
BMJ. 2005 May 14;330(7500):1106. doi: 10.1136/bmj.330.7500.1106-a.

No abstract available.

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Lenzer J. New law aims to distance the FDA from the drug industry. BMJ. 2005;330(7500):1106doi: 10.1136/bmj.330.7500.1106-a.
Lenzer, J. (2005). New law aims to distance the FDA from the drug industry. BMJ (Clinical research ed.), 330(7500), 1106. https://doi.org/10.1136/bmj.330.7500.1106-a
Lenzer, Jeanne. "New law aims to distance the FDA from the drug industry." BMJ (Clinical research ed.) vol. 330,7500 (2005): 1106. doi: https://doi.org/10.1136/bmj.330.7500.1106-a
Lenzer J. New law aims to distance the FDA from the drug industry. BMJ. 2005 May 14;330(7500):1106. doi: 10.1136/bmj.330.7500.1106-a. PMID: 15891225; PMCID: PMC557934.
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Repeal law that puts "FDA on the payroll of the industry," says former NEJM editor.

BMJ (Clinical research ed.)

Kmietowicz Z.
PMID: 17332569
BMJ. 2007 Mar 03;334(7591):447. doi: 10.1136/bmj.39140.456030.DB.

No abstract available.

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Kmietowicz Z. Repeal law that puts "FDA on the payroll of the industry," says former NEJM editor. BMJ. 2007;334(7591):447doi: 10.1136/bmj.39140.456030.DB.
Kmietowicz, Z. (2007). Repeal law that puts "FDA on the payroll of the industry," says former NEJM editor. BMJ (Clinical research ed.), 334(7591), 447. https://doi.org/10.1136/bmj.39140.456030.DB
Kmietowicz, Zosia. "Repeal law that puts "FDA on the payroll of the industry," says former NEJM editor." BMJ (Clinical research ed.) vol. 334,7591 (2007): 447. doi: https://doi.org/10.1136/bmj.39140.456030.DB
Kmietowicz Z. Repeal law that puts "FDA on the payroll of the industry," says former NEJM editor. BMJ. 2007 Mar 03;334(7591):447. doi: 10.1136/bmj.39140.456030.DB. PMID: 17332569; PMCID: PMC1808190.
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FDA perspective on trials with interim efficacy evaluations.

Statistics in medicine

Temple R.
PMID: 16847824
Stat Med. 2006 Oct 15;25(19):3245-9; discussion 3326-47. doi: 10.1002/sim.2631.

Over the years FDA has seen a variety of 'adaptive' approaches, including repeated calculation of p-values. More recently there has been interest in adjusting sample sizes based on event rates, easy if the treatment group rates remain blinded but...

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Temple R. FDA perspective on trials with interim efficacy evaluations. Stat Med. 2006;25(19):3245-9; discussion 3326-47doi: 10.1002/sim.2631.
Temple, R. (2006). FDA perspective on trials with interim efficacy evaluations. Statistics in medicine, 25(19), 3245-9; discussion 3326-47. https://doi.org/10.1002/sim.2631
Temple, Robert. "FDA perspective on trials with interim efficacy evaluations." Statistics in medicine vol. 25,19 (2006): 3245-9; discussion 3326-47. doi: https://doi.org/10.1002/sim.2631
Temple R. FDA perspective on trials with interim efficacy evaluations. Stat Med. 2006 Oct 15;25(19):3245-9; discussion 3326-47. doi: 10.1002/sim.2631. PMID: 16847824.
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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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Negotiated rulemaking: the next step in regulatory innovation at the Food and Drug Administration?.

Food and drug law journal

Kobick J.
PMID: 24475549
Food Drug Law J. 2010;65(2):425-45, iv.

Negotiated rulemaking is a regulatory tool designed to build consensus on regulations before notice and comment rulemaking procedures. An agency convenes a negotiation with relevant stakeholders to work together to develop a draft rule. In theory, consensus on a...

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Kobick J. Negotiated rulemaking: the next step in regulatory innovation at the Food and Drug Administration?. Food Drug Law J. 2010;65(2):425-45, iv
Kobick, J. (2010). Negotiated rulemaking: the next step in regulatory innovation at the Food and Drug Administration?. Food and drug law journal, 65(2), 425-45, iv.
Kobick, Julia. "Negotiated rulemaking: the next step in regulatory innovation at the Food and Drug Administration?." Food and drug law journal vol. 65,2 (2010): 425-45, iv.
Kobick J. Negotiated rulemaking: the next step in regulatory innovation at the Food and Drug Administration?. Food Drug Law J. 2010;65(2):425-45, iv. PMID: 24475549.
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FDA Oversight of Laboratory-Developed Tests: Where Are We Now?.

Archives of pathology & laboratory medicine

Gatter K.
PMID: 28557601
Arch Pathol Lab Med. 2017 Jun;141(6):746-748. doi: 10.5858/arpa.2017-0053-ED. Epub 2017 Mar 03.

No abstract available.

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Gatter K. FDA Oversight of Laboratory-Developed Tests: Where Are We Now?. Arch Pathol Lab Med. 2017;141(6):746-748doi: 10.5858/arpa.2017-0053-ED.
Gatter, K. (2017). FDA Oversight of Laboratory-Developed Tests: Where Are We Now?. Archives of pathology & laboratory medicine, 141(6), 746-748. https://doi.org/10.5858/arpa.2017-0053-ED
Gatter, Ken. "FDA Oversight of Laboratory-Developed Tests: Where Are We Now?." Archives of pathology & laboratory medicine vol. 141,6 (2017): 746-748. doi: https://doi.org/10.5858/arpa.2017-0053-ED
Gatter K. FDA Oversight of Laboratory-Developed Tests: Where Are We Now?. Arch Pathol Lab Med. 2017 Jun;141(6):746-748. doi: 10.5858/arpa.2017-0053-ED. Epub 2017 Mar 03. PMID: 28557601.
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Regulatory Landscape in the United States.

Clinical pharmacology and therapeutics

Vetter PL.
PMID: 30536861
Clin Pharmacol Ther. 2019 Jan;105(1):26-28. doi: 10.1002/cpt.1243. Epub 2018 Dec 07.

No abstract available.

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Vetter PL. Regulatory Landscape in the United States. Clin Pharmacol Ther. 2018;105(1):26-28doi: 10.1002/cpt.1243.
Vetter, P. L. (2019). Regulatory Landscape in the United States. Clinical pharmacology and therapeutics, 105(1), 26-28. https://doi.org/10.1002/cpt.1243
Vetter, Pamela L. "Regulatory Landscape in the United States." Clinical pharmacology and therapeutics vol. 105,1 (2019): 26-28. doi: https://doi.org/10.1002/cpt.1243
Vetter PL. Regulatory Landscape in the United States. Clin Pharmacol Ther. 2019 Jan;105(1):26-28. doi: 10.1002/cpt.1243. Epub 2018 Dec 07. PMID: 30536861.
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FDA's FDAMA accomplishments--one year after enactment.

The Annals of pharmacotherapy

[No authors listed]
PMID: 9972401
Ann Pharmacother. 1999 Jan;33(1):134.

No abstract available.

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FDA's FDAMA accomplishments--one year after enactment. Ann Pharmacother. 1999;33(1):134
(1999). FDA's FDAMA accomplishments--one year after enactment. The Annals of pharmacotherapy, 33(1), 134.
"FDA's FDAMA accomplishments--one year after enactment." The Annals of pharmacotherapy vol. 33,1 (1999): 134.
FDA's FDAMA accomplishments--one year after enactment. Ann Pharmacother. 1999 Jan;33(1):134. PMID: 9972401.
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Prospects for Enforcing Prohibitions on Off-Label Drug Promotion after United States v. Caronia: An Analysis of Litigated Cases.

Journal of health politics, policy and law

Liu S, Mello MM, Kesselheim AS.
PMID: 33647951
J Health Polit Policy Law. 2021 Jun 01;46(3):487-504. doi: 10.1215/03616878-8893571.

CONTEXT: Food and Drug Administration (FDA) rules restrict pharmaceutical manufacturers from promoting drugs for non-FDA-approved (off-label) indications. When manufacturers violate this rule, it has in many cases led to unsafe prescribing. However, in 2012, a federal circuit court ruled...

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Liu S, Mello MM, Kesselheim AS. Prospects for Enforcing Prohibitions on Off-Label Drug Promotion after United States v. Caronia: An Analysis of Litigated Cases. J Health Polit Policy Law. 2021;46(3):487-504doi: 10.1215/03616878-8893571.
Liu, S., Mello, M. M., & Kesselheim, A. S. (2021). Prospects for Enforcing Prohibitions on Off-Label Drug Promotion after United States v. Caronia: An Analysis of Litigated Cases. Journal of health politics, policy and law, 46(3), 487-504. https://doi.org/10.1215/03616878-8893571
Liu, Sheng, et al. "Prospects for Enforcing Prohibitions on Off-Label Drug Promotion after United States v. Caronia: An Analysis of Litigated Cases." Journal of health politics, policy and law vol. 46,3 (2021): 487-504. doi: https://doi.org/10.1215/03616878-8893571
Liu S, Mello MM, Kesselheim AS. Prospects for Enforcing Prohibitions on Off-Label Drug Promotion after United States v. Caronia: An Analysis of Litigated Cases. J Health Polit Policy Law. 2021 Jun 01;46(3):487-504. doi: 10.1215/03616878-8893571. PMID: 33647951.
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Implementing the FDA Modernization Act.

JAMA

Marwick C.
PMID: 9515981
JAMA. 1998 Mar 18;279(11):815-6. doi: 10.1001/jama.279.11.815.

No abstract available.

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Marwick C. Implementing the FDA Modernization Act. JAMA. 1998;279(11):815-6doi: 10.1001/jama.279.11.815.
Marwick, C. (1998). Implementing the FDA Modernization Act. JAMA, 279(11), 815-6. https://doi.org/10.1001/jama.279.11.815
Marwick, C. "Implementing the FDA Modernization Act." JAMA vol. 279,11 (1998): 815-6. doi: https://doi.org/10.1001/jama.279.11.815
Marwick C. Implementing the FDA Modernization Act. JAMA. 1998 Mar 18;279(11):815-6. doi: 10.1001/jama.279.11.815. PMID: 9515981.
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Showing 1 to 12 of 77 entries