FDA FDA 1501 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Are IDE records released to the public? 1.31K viewsFDA 0 Votes 1 Ans Can I receive advice from FDA on non-clinical testing and/or on my clinical protocol? 1.25K viewsFDA 0 Votes 1 Ans Do clinical studies have to be conducted in the U.S. / Will foreign studies be accepted? 1.42K viewsFDA 0 Votes 1 Ans Do the IDE regulations apply to in vitro diagnostic devices? 998 viewsFDA 0 Votes 1 Ans Are there special labeling requirements for investigational devices? 1.30K viewsFDA 0 Votes 1 Ans Can I advertise my investigational device? What other restrictions apply? 1.33K viewsFDA 0 Votes 1 Ans Will insurance cover treatment with an investigational device? 1.19K viewsFDA 0 Votes 1 Ans Does the contact person’s signature need to be on the cover letter of the orphan drug designation request? Do you need an original signature? Can a signature page be sent separately? 1.36K viewsFDA 0 Votes 1 Ans Can the orphan drug designation request be submitted electronically? What is required? If so, how? 1.33K viewsFDA 0 Votes 1 Ans What information about orphan drug designations is publicly available? What if the sponsor does not provide a generic and trade name of the drug? 1.34K viewsFDA 0 Votes 1 Ans What is the review process like once the orphan drug designation request is received in OOPD? 1.26K viewsFDA 0 Votes 1 Ans The regulations say that the sponsor is required to submit all relevant data about their drug in the orphan drug designation request. Why doesn’t the sponsor have to submit animal toxicology data in the orphan drug designation request? 1.31K viewsFDA 0 Votes 1 Ans What information is required for an orphan drug designation request? How should the request be formatted? 1.43K viewsFDA 0 Votes 1 Ans Who regulates ELDU and enforces the regulations? 1.81K viewsFDA 0 Votes 1 Ans How do I know what qualifies as ELDU? 1.25K viewsFDA 0 Votes 1 Ans What drugs qualify for ELDU? 1.11K viewsFDA 0 Votes 1 Ans When is ELDU used/necessary? 1.58K viewsFDA 0 Votes 1 Ans What drugs are currently restricted from ELDU? 1.47K viewsFDA 0 Votes 1 Ans Some ELDU documentation requires listing a withdrawal time. What is that and why is it necessary? 1.45K viewsFDA 0 Votes 1 Ans Where do I find information about withdrawal period information for ELDU in food-producing animals? 1.59K viewsFDA « Previous 1 2 … 17 18 19 20 21 … 75 76 Next » Question and answer is powered by anspress.net
