Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans What should be considered in performing an assessment of whether a firm’s drug product, or its components or packaging materials may have been contaminated with radioactive material? 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the FDA doing to ensure the safety of drugs coming from Japan? 1.70K viewsDrugsPharmaceutical 0 Votes 1 Ans Why FDA paying special attention to injectable and inhalable drugs? 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the FDA-approved products for treatment of internal contamination with radioactive iodine? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans Is potassium iodide the only medication available for radiation exposure? 1.34K viewsDrugsPharmaceutical 0 Votes 1 Ans We have heard that potassium iodide is in short supply. Is that correct? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans Have U.S. manufacturers of potassium iodide been asked to ship any products to Japan? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans Can a sponsor of an investigational new drug export its product to Japan? Does FDA have to authorize such an export? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the GLPs apply to all of the analytical support work conducted to provide supplementary data to a safety study? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans What kinds of domestic toxicology laboratory inspections? does FDA perform and how frequently are they done? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans For drug products formulated with preservatives to inhibit microbial growth, is it necessary to test for preservatives as part of batch release and stability testing? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the benefits of implementing a pharmaceutical quality system (PQS) (in accordance with ICH Q10)? 1.67K viewsDrugsPharmaceutical 0 Votes 1 Ans How does a company demonstrate implementation of PQS in accordance with ICH Q10? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans How will product-related inspections differ in an ICH Q8, Q9 and Q10 environment? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans How will system-related inspections differ in an ICH Q8, Q9, and Q10 environment? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans Why is FDA concerned about drug contamination with halogenated anisole compounds, such as 2,4,6-tribromoanisole (TBA)? 1.69K viewsDrugsPharmaceutical 0 Votes 1 Ans Has FDA identified the source of the halogenated anisole compounds that have contaminated drug products? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans What is FDA’s expectation for preventing contamination of drug products with halogenated anisole compounds? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans Many leading analytical balance manufacturers provide built-in “auto-calibration” features in their balances. Are such auto-calibration procedures acceptable instead of external performance checks? If not, then what should the schedule for calibration be? 1.32K viewsDrugsPharmaceutical 0 Votes 1 Ans Can FDA mandate a recall of human drugs? 1.34K viewsDrugsPharmaceutical « Previous 1 2 … 12 13 14 15 16 … 82 83 Next » Question and answer is powered by anspress.net
