US Food and Drug Administration regulatory oversight of laboratory-developed tests: Commentary on the draft guidance

2015 ◽  
Vol 123 (10) ◽  
pp. 573-575 ◽  
Author(s):  
Mary K. Sidawy
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Draft Guidance ◽  
Regulatory Oversight

Comments on the Draft Guidance on “Adaptive Design Clinical Trials for Drugs and Biologics” of the U.S. Food and Drug Administration

2010 ◽  
Vol 20 (6) ◽  
pp. 1125-1131 ◽  
Author(s):  
Werner Brannath ◽  
Hans Ulrich Burger ◽  
Ekkehard Glimm ◽  
Nigel Stallard ◽  
Marc Vandemeulebroecke ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Administration ◽  
Adaptive Design ◽  
Food And Drug Administration ◽  
Draft Guidance ◽  
The U.S

Pharmacogenomics: An In-House Advantage?

2005 ◽  
Vol 2 (5) ◽  
Author(s):  
Paul E. Borchardt ◽  
Dennis S. Fernandez
Keyword(s):  
Genetic Testing ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Drug Approval ◽  
Regulatory Oversight ◽  
Diagnostic Kits ◽  
Future Drug

AbstractIntroductionWith the expectation that future drug approval may hinge on pharmacogenomic testing of patients, what are the advantages of the in-house testing of patient samples compared to supplying diagnostic kits? The genetic testing industry provides an interesting reference from which to examine this question. The genetic testing industry falls chiefly under the less stringent, regulatory oversight of the Centers for Medicare and Medicaid Services (CMS) and not the Food and Drug Administration (FDA). Genetic testing is also a service and not a product, with different, perhaps lesser, legal liabilities. Additionally, in-house testing may provide unique business advantages. This article examines the genetic testing industry and how the benefits of in-house testing may apply to the nascent pharmacogenomics industry.

The Use of Unallowed Excipients

2003 ◽  
Vol 22 (5) ◽  
pp. 373-375 ◽  
Author(s):  
Marshall Steinberg ◽  
Irwin Silverstein
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Draft Guidance ◽  
National Formulary ◽  
Pharmaceutical Excipients ◽  
The U.S

The laws governing the U.S. Food and Drug Administration (FDA) do not provide for the approval of stand-alone excipients. Current regulations do not permit the use of excipients, but allow their use. The acceptance process for excipients is slow and only recently did the FDA propose draft guidance for nonclinical studies for pharmaceutical excipients. The FDA has made four suggestions to the U.S. Pharmacopoeia concerning including excipient monographs in the National Formulary for excipients not yet allowed. This article reviews these four proposals to identify the proposal that is most appropriate.

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