FDA FDA 1501 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Is there a charge for listing studies on ClinicalTrials.gov? 1.92K viewsFDA 0 Votes 1 Ans My study is not yet approved by a human subjects review board (ethics review committee, institutional review board). Can I enter it on ClinicalTrials.gov? 1.86K viewsFDA 0 Votes 1 Ans Why can’t I find my study on ClinicalTrials.gov? 1.89K viewsFDA 0 Votes 1 Ans When will the NCT Number for my study be assigned? 1.73K viewsFDA 0 Votes 1 Ans Can I register a study after it has started, has closed to recruitment, or has been completed? 1.55K viewsFDA 0 Votes 1 Ans Must clinical studies with no external sources of funding (“unfunded” studies) be registered on ClinicalTrials.gov? 1.93K viewsFDA 0 Votes 1 Ans How do I contact ClinicalTrials.gov if I have a question about my study record? 1.72K viewsFDA 0 Votes 1 Ans Do I need to register each single-patient investigational new drug application (IND) or protocol exception (including for emergency use) separately? 1.74K viewsFDA 0 Votes 1 Ans Can an organization have multiple users for a single account? 1.60K viewsFDA 0 Votes 1 Ans Can registration and results information be uploaded electronically to ClinicalTrials.gov? 1.54K viewsFDA 0 Votes 1 Ans To comply with FDAAA 801, must I submit information to ClinicalTrials.gov, or can I use another registry or results database? 1.85K viewsFDA 0 Votes 1 Ans To comply with FDAAA 801, must I submit information to ClinicalTrials.gov, or can I use another registry or results database? 1.60K viewsFDA 0 Votes 1 Ans Does FDAAA 801 only apply to industry-sponsored studies? 1.87K viewsFDA 0 Votes 1 Ans Does the definition of applicable clinical trial under FDAAA 801 only include studies conducted under an FDA Investigational New Drug Application (IND) or Investigational Device Exemption (IDE)? 1.80K viewsFDA 0 Votes 1 Ans Where do we send the portfolio plan? 1.61K viewsFDA 0 Votes 1 Ans What are the differences between MEDDEV 2.7.1 Rev. 4 and MDR clinical evaluation requirements? 1.85K viewsFDA 0 Votes 1 Ans Is there a template that could be used for CER that is in compliance with the new MDR? Considering Adverse event database for a device…would not the device sales be the denominator? If a competitor’s device is similar, for example, to a hemodialysis catheter, can literature about that device be used or excluded? Is a contract required to use that data? 1.81K viewsFDA 0 Votes 1 Ans Do we really need to gain access to our competitor’s technical files to show equivalence for the CERs? 1.79K viewsFDA 0 Votes 1 Ans Is the Clinical Evaluation Plan the best place to document our position on our CER approach and gain alignment with the Notified Body as needed? 1.60K viewsFDA 0 Votes 1 Ans Intended use vs. indications for use. Some older products do not have indications for use. Do you need to redefine intended use to include all indications, or can you use a risk-based approach and use evidence for one high risk indication? 1.64K viewsFDA « Previous 1 2 … 65 66 67 68 69 … 75 76 Next » Question and answer is powered by anspress.net
