FDA FDA 1501 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans What is a Preventive Controls Qualified Individual (PCQI)? 1.30K viewsFDA 0 Votes 1 Ans Who should be my company PCQI? 991 viewsFDA 0 Votes 1 Ans How to become a Verified Foreign Supplier to the U.S. market? 1.29K viewsFDA 0 Votes 1 Ans Is the certification to a GFSI recognized scheme enough to comply with FSMA? 1.22K viewsFDA 0 Votes 1 Ans If the sponsor is from a foreign country, is a U.S. agent required in order to file a designation request? What is needed from a U.S. agent? What are they responsible for? 1.06K viewsFDA 0 Votes 1 Ans What if the sponsor has difficulty finding data on prevalence? What if data are not available? What are the best prevalence estimate resources? What should a sponsor do if the best resource they can find is 10-20 years old (or only from other countries)? 1.07K viewsFDA 0 Votes 1 Ans In the case of a product used for an “acute” condition, should incidence of < 200,000 be used instead of prevalence? 1.27K viewsFDA 0 Votes 1 Ans If the intended designated use of a drug is for “prevention” versus for “treatment”, how is the population estimated in each case? 1.10K viewsFDA 0 Votes 1 Ans Is there a general list (besides OOPD database) of specific conditions considered to have prevalence of <200,000? 1.21K viewsFDA 0 Votes 1 Ans Under what conditions will OOPD designate an orphan drug and recognize orphan drug exclusivity for a new formulation of a drug that is otherwise the same drug as an already approved drug for the same rare disease or condition? 1.19K viewsFDA 0 Votes 1 Ans What does OOPD consider a “major contribution to patient care?” 1.33K viewsFDA 0 Votes 1 Ans If changes are made to the product formulation (such as solution form instead of emulsion versus intravenous, subcutaneous, intrathecal, intranasal or oral or a different concentration is formulated) after receiving orphan designation and prior to NDA submission, will the approved NDA still qualify for exclusivity? 1.24K viewsFDA 0 Votes 1 Ans Are generic drugs as safe and effective as brand drugs? 1.12K viewsFDA 0 Votes 1 Ans How are generic drugs approved? 1.19K viewsFDA 0 Votes 1 Ans Why does a generic drug look different from the brand drug? 1.06K viewsFDA 0 Votes 1 Ans Are all brand drugs available in generic form? 1.29K viewsFDA 0 Votes 1 Ans Why are the names of brand drugs so different from the names of generic drugs? 1.12K viewsFDA 0 Votes 1 Ans Do generic medicines work the same as brand-name medicines? 1.24K 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? 1.09K 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? 1.12K viewsFDA « Previous 1 2 … 16 17 18 19 20 … 75 76 Next » Question and answer is powered by anspress.net
