Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Are there any risks involved in participating in a research study? 1.52K viewsFDA 0 Votes 1 Ans Will my privacy be protected if I take part in a clinical trial? 1.55K viewsFDA 0 Votes 1 Ans We make different devices at different establishments that are listed under the same device product code or submission number. Do we need to identify proprietary names on an establishment-by-establishment basis? 1.50K viewsFDA 0 Votes 1 Ans Now that a foreign establishment is required to provide the names of all known importers of its devices, must it continue to update this information in FURLS whenever it changes? 1.54K viewsFDA 0 Votes 1 Ans As an importer, I am now required to provide the manufacturer information for devices I will be importing. Must I update this information in FURLS as new firms are added or I decide to no longer distribute for a particular manufacturer? 1.43K viewsFDA 0 Votes 1 Ans I am a foreign exporter, contract manufacturer, or contract sterilizer and I am trying to list a non-exempt device and FURLS will not allow me to proceed. Why can I not list this device? 1.49K viewsFDA 0 Votes 1 Ans What are the different types of accounts in the FDA Unified Registration and Listing System (FURLS) that are used to access the Device Registration and Listing Module (DRLM)? 1.60K viewsFDA 0 Votes 1 Ans When is it appropriate to look at the contents of a QA report? 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans What registration information must I submit if my applicable clinical trial is required to be registered? 1.78K viewsFDA 0 Votes 1 Ans When must I submit the required clinical trial registration information? 1.47K viewsFDA 0 Votes 1 Ans How are examinations by telephone call or other electronic means considered in determining when an applicable clinical trial reaches its “primary completion date” or “study completion date” under the regulation? 1.54K viewsFDA 0 Votes 1 Ans At what point is a human subject considered to be “enrolled” in an applicable clinical trial? 1.64K viewsFDA 0 Votes 1 Ans What is the Primary Completion Date and/or Study Completion Date when an outcome is measured or assessed after a study participant has been examined or received an intervention for that outcome? 1.65K viewsFDA 0 Votes 1 Ans Am I required to submit results information for my applicable clinical trial (ACT)? 1.55K viewsFDA 0 Votes 1 Ans When is required clinical trial results information due? 1.56K viewsFDA 0 Votes 1 Ans Is a protocol and statistical analysis plan (SAP) required to be submitted? 1.40K viewsFDA 0 Votes 1 Ans What is the results information submission deadline for applicable clinical trials (ACTs) of drug, biological, or device products that are not approved, licensed, or cleared for any use and studied in conjunction with, or in comparison to, approved, licensed, or cleared products? 1.38K viewsFDA 0 Votes 1 Ans How are “approval, licensure, or clearance of a new use” and “initial approval, licensure, or clearance” defined for the purposes of determining if a study may qualify for delayed submission of results information with certification? 1.14K viewsFDA 0 Votes 1 Ans When must I update clinical trial registration information? 1.73K viewsFDA 0 Votes 1 Ans What are the requirements for updating clinical trial registration information when a Human Subjects Review Board approves a protocol amendment? 1.55K viewsFDA « Previous 1 2 … 251 252 253 254 255 … 283 284 Next » Question and answer is powered by anspress.net
