Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans How long do the three pilot scale batches, submitted as a part of an ANDA, need to be stored before destruction? 1.65K viewsFDA 0 Votes 1 Ans How many months of long-term and accelerated data are required when a “Completeness Assessment” is performed on the DMF? Also, what should the DMF stability section contain for a Completeness Assessment? 1.57K viewsFDA 0 Votes 1 Ans Are stability data from three current good manufacturing practice (CGMP) batches required to be filed in the DMF to support the API retest date? Also, how many months of long-term and accelerated data are required for pilot scale batches? 1.55K viewsFDA 0 Votes 1 Ans Will submissions to DMFs be accepted based on stability data from production scale batches? 1.41K viewsFDA 0 Votes 1 Ans Can investigational IVD studies receive expedited review (see Glossary for definition) by an IRB? 1.47K viewsFDA 0 Votes 1 Ans Can leftover specimens be used in IVD studies without informed consent? 1.52K viewsFDA 0 Votes 1 Ans Can those who routinely conduct studies with IVDs (e.g., research hospitals) use a general informed consent to address future studies using samples collected in their own facility? 1.55K viewsFDA 0 Votes 1 Ans Can a human specimen that was initially collected in a study with the informed consent of the subject be used in a later study without a new consent process? 1.27K viewsFDA 0 Votes 1 Ans What information should the protocol include to ensure that the investigational IVD study will be scientifically sound? 1.66K viewsFDA 0 Votes 1 Ans Is it acceptable to develop new or to revise existing study hypotheses as the study progresses? 1.53K viewsFDA 0 Votes 1 Ans How should I determine appropriate sample size for a study? 1.61K viewsFDA 0 Votes 1 Ans What guidance is available for sponsors to determine how to estimate IVD performance in terms of sensitivity and specificity, how to handle discrepant results, and what to do when a study is performed without a truth standard (“gold standard”) (see the Glossary for definitions)? 1.60K viewsFDA 0 Votes 1 Ans How much leeway is there in deciding on the populations from which human specimens are collected and under what conditions are data on simulated specimens acceptable? 1.09K views 0 Votes 1 Ans Is it acceptable to eliminate data that appear to be out of line with the main body of the dataset (i.e., “outliers”)? 1.50K viewsFDA 0 Votes 1 Ans Can I add additional testing on the same subject to the dataset, particularly when it is hard to find study subjects? 1.58K viewsFDA 0 Votes 1 Ans How much precision is needed for measurement data, e.g., in terms of decimal places? 1.30K viewsFDA 0 Votes 1 Ans What records should help to ensure scientific soundness of an IVD investigational study? 1.41K viewsFDA 0 Votes 1 Ans What does FDA recommend be included in the final report of the investigation from the sponsor to all reviewing IRBs (and to FDA for significant risk studies) (21 CFR 812.150(b)(7))? 1.46K viewsFDA 0 Votes 1 Ans What is the scope of and implementation date for the FDA stability guidance? 1.67K viewsFDA 0 Votes 1 Ans What is a master file and how is one submitted? 1.43K viewsFDA « Previous 1 2 … 143 144 145 146 147 … 283 284 Next » Question and answer is powered by anspress.net
