Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans What standards must generic medicines meet to receive FDA approval? 932 viewsFDA 0 Votes 1 Ans Is a generic version of my brand-name medicine available? 1.34K viewsFDA 0 Votes 1 Ans Does FDA monitor side effects or safety issues with generic medicines? 1.17K viewsFDA 0 Votes 1 Ans Who is going to check if I comply with FSMA? 1.16K viewsFDA 0 Votes 1 Ans Is my existing FDA registration enough to comply with FSMA? 1.04K viewsFDA 0 Votes 1 Ans Why are the Foreign Supplier Verification Program (FSVP) requirements important for the exporters, based in countries different than USA? 1.32K viewsFDA 0 Votes 1 Ans What is a Preventive Controls Qualified Individual (PCQI)? 1.31K viewsFDA 0 Votes 1 Ans As PCQI, is completing a PCQI training course the only thing I need to do? 1.16K views 0 Votes 1 Ans Who should be my company PCQI? 1.00K viewsFDA 0 Votes 1 Ans How to become a Verified Foreign Supplier to the U.S. market? 1.30K viewsFDA 0 Votes 1 Ans Is the certification to a GFSI recognized scheme enough to comply with FSMA? 1.23K 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? 1.08K 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)? 1.08K 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? 1.28K 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? 1.11K viewsFDA 0 Votes 1 Ans Is there a general list (besides OOPD database) of specific conditions considered to have prevalence of <200,000? 1.22K 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? 1.20K viewsFDA 0 Votes 1 Ans What does OOPD consider a “major contribution to patient care?” 1.34K 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? 1.25K viewsFDA 0 Votes 1 Ans Are generic drugs as safe and effective as brand drugs? 1.13K viewsFDA « Previous 1 2 … 151 152 153 154 155 … 283 284 Next » Question and answer is powered by anspress.net
