Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans How are generic drugs approved? 1.23K viewsFDA 0 Votes 1 Ans Why does a generic drug look different from the brand drug? 1.12K viewsFDA 0 Votes 1 Ans Are all brand drugs available in generic form? 1.34K viewsFDA 0 Votes 1 Ans Why are the names of brand drugs so different from the names of generic drugs? 1.19K viewsFDA 0 Votes 1 Ans Do generic medicines work the same as brand-name medicines? 1.29K viewsFDA 0 Votes 1 Ans If my device has been approved and marketed in a foreign country and I am conducting clinical trials in the U.S., should I report an adverse event from the U.S. trial under the IDE program or the Medical Device Reporting (MDR) program? 1.15K viewsFDA 0 Votes 1 Ans My device is marketed in the U.S. I am conducting a clinical trial in the U.S. for the same device, but for a different indication for use, should I report an adverse event under the IDE program or the MDR program? 1.17K viewsFDA 0 Votes 1 Ans Are IDE records released to the public? 1.20K viewsFDA 0 Votes 1 Ans Can I receive advice from FDA on non-clinical testing and/or on my clinical protocol? 1.14K viewsFDA 0 Votes 1 Ans Do clinical studies have to be conducted in the U.S. / Will foreign studies be accepted? 1.29K viewsFDA 0 Votes 1 Ans Do the IDE regulations apply to in vitro diagnostic devices? 876 viewsFDA 0 Votes 1 Ans Are there special labeling requirements for investigational devices? 1.18K viewsFDA 0 Votes 1 Ans Can I advertise my investigational device? What other restrictions apply? 1.21K viewsFDA 0 Votes 1 Ans Will insurance cover treatment with an investigational device? 974 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? 1.24K viewsFDA 0 Votes 1 Ans Can the orphan drug designation request be submitted electronically? What is required? If so, how? 1.22K 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? 1.23K viewsFDA 0 Votes 1 Ans What is the review process like once the orphan drug designation request is received in OOPD? 1.14K 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? 1.02K viewsFDA 0 Votes 1 Ans What information is required for an orphan drug designation request? How should the request be formatted? 1.31K viewsFDA « Previous 1 2 … 152 153 154 155 156 … 283 284 Next » Question and answer is powered by anspress.net
