Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications to Accompany Drug, Biological Product, and Device Applications/Submissions

2008 ◽  
Vol 27 (4) ◽  
pp. 336-337
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Draft Guidance ◽  
Biological Product ◽  
Device Applications

Comments on the Draft Guidance on “Adaptive Design Clinical Trials for Drugs and Biologics” of the U.S. Food and Drug Administration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Draft Guidance ◽  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

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Draft Guidance ◽  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 The acceptance process for excipients is slow and only recently did the FDA propose draft guidance for nonclinical studies for pharmaceutical excipients.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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