Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans What information does the final rule require from each IRB in the U.S. that reviews FDA regulated studies? 1.27K viewsFDA 0 Votes 1 Ans Once my IRB is registered or its existing information is updated to comply with this rule, is registration permanent unless there is a change in required information? 1.51K viewsFDA 0 Votes 1 Ans Once registered, when is an IRB required to revise its registration information? 1.43K viewsFDA 0 Votes 1 Ans Do IRBs need to update the number of active protocols under review when changes occur? 1.58K viewsFDA 0 Votes 1 Ans What are the consequences of an IRB failing to register as required by the final rule? 1.69K viewsFDA 0 Votes 1 Ans Will the information in the registration system be available to the public? 1.53K viewsFDA 0 Votes 1 Ans What documentation should the sponsor or applicant provide regarding investigator qualifications? 1.58K viewsFDA 0 Votes 1 Ans Is the name and address of the research facility a sufficient description to address this requirement? 1.47K viewsFDA 0 Votes 1 Ans Does FDA have a list of substances that are used in food on the basis of the GRAS provision? 1.52K viewsFDA 0 Votes 1 Ans Can the use of a substance be GRAS even if it is not listed by FDA? 1.56K viewsFDA 0 Votes 1 Ans Why did I receive an invalid certificate error? 1.63K viewsFDA 0 Votes 1 Ans Why did I receive a signing encryption error? 916 viewsFDA 0 Votes 1 Ans When registering for another account, an error is received that says “Company name already exists”. How can this error be addressed? 1.38K viewsFDA 0 Votes 1 Ans Is it possible for a company to use both the FDA ESG web interface and the Gateway-to-Gateway exchange with the FDA ESG? For example, a company may want to send ISCR reports via the Gateway-to-Gateway exchange and other submissions via the FDA ESG web interface. 1.66K viewsFDA 0 Votes 1 Ans What are FDA drug approval packages? 1.64K viewsFDA 0 Votes 1 Ans How will OpenTrialsFDA improve access to the FDA data? 1.48K viewsFDA 0 Votes 1 Ans How does the FDA review process differ from the peer review process used for manuscripts submitted to journals? 1.59K viewsFDA 0 Votes 1 Ans Who authors FDA reviews? 1.69K viewsFDA 0 Votes 1 Ans Are you sure that the use you’re interested in is not off-label, ie. that the FDA approved it for the indication you’re interested in? 1.61K viewsFDA 0 Votes 1 Ans Did you use the generic name or brand name? 1.58K viewsFDA « Previous 1 2 … 147 148 149 150 151 … 283 284 Next » Question and answer is powered by anspress.net
