Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Why is FDA paying special attention to injectable and inhalable drugs? 1.67K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the FDA approved products for treatment of internal contamination with radioactive iodine? 1.70K viewsDrugsPharmaceutical 0 Votes 1 Ans Is potassium iodide the only medication available for radiation exposure? 1.69K viewsDrugsPharmaceutical 0 Votes 1 Ans We have heard that potassium iodide is in short supply. Is that correct? 1.61K viewsDrugsPharmaceutical 0 Votes 1 Ans Have there been discussions with WHO regarding the pre-clearance process for IVDs and taking account the results of an MDSAP audit? Will medical devices assessed by the WHO be included in the program at a later stage? 1.72K viewsMedical Device 0 Votes 1 Ans What is the best way to determine what is expected of the Auditing Organizations with regard to multiple jurisdictions? 1.89K viewsMedical Device 0 Votes 1 Ans What do you think might be the biggest difference between the requirements of FDA’s device requirements and the EU’s MDR? 1.58K viewsMedical Device 0 Votes 1 Ans How does FDA classify medical devices? 1.68K viewsMedical Device 0 Votes 1 Ans What is a premarket notification (510(k)) submission? 1.84K viewsMedical Device 0 Votes 1 Ans What is a premarket approval (PMA) application? 1.76K viewsMedical Device 0 Votes 1 Ans What is a humanitarian device exemption (HDE) application? 1.46K viewsMedical Device 0 Votes 1 Ans What are the responsibilities of the IRBs regarding HDEs? 1.70K viewsMedical Device 0 Votes 1 Ans Does FDA require IRB review and approval of off-label use of a legally marketed device? 1.80K viewsMedical Device 0 Votes 1 Ans Must an IRB review a study conducted after submission of a (510(k)) to FDA but prior to FDA’s decision on that submission? 1.88K viewsMedical Device 0 Votes 1 Ans Can a physician use an unapproved device in an emergency? 1.84K viewsMedical Device 0 Votes 1 Ans What if the situation is not an emergency? Can a patient with a serious illness or condition have access to an investigational device outside a study? 1.68K viewsMedical Device 0 Votes 1 Ans What prompted development of the Concept of Operations (ConOps)? 1.96K viewsFDA 0 Votes 1 Ans How does FDA communicate the final inspection classification? 1.53K viewsFDA 0 Votes 1 Ans Is the agency updating internal policies and procedural documents to reflect the ConOps? 1.77K viewsFDA 0 Votes 1 Ans Can FDA mandate a recall of human drugs? 1.77K viewsDrugsPharmaceutical « Previous 1 2 … 276 277 278 279 280 … 283 284 Next » Question and answer is powered by anspress.net
