FDA FDA 1501 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Does FDA require that medical foods be made available by written or oral prescription? 863 viewsFDA 0 Votes 1 Ans What’s your advice to companies that receive a Form FDA-483? 1.08K viewsFDA 0 Votes 1 Ans What is the Good Tissue Practice? 1.16K viewsFDA 0 Votes 1 Ans What is Current Good Tissue Practice? 1.16K viewsFDA 0 Votes 1 Ans What are the CGTP Requirements? 942 viewsFDA 0 Votes 1 Ans How can MasterControl help tissue establishments facilitate GTP compliance? 989 viewsFDA 0 Votes 1 Ans Does the Principal Investigator (PI) have to be 100% available for the whole duration of the audit? 1.01K viewsFDA 0 Votes 1 Ans Do all staff members need to have Good Clinical Practice (GCP) and Human Subject Protection Training (HSP)? 1.06K viewsFDA 0 Votes 1 Ans What are some tips for clearly showing PI oversight of a study? 909 viewsFDA 0 Votes 1 Ans What are some ‘quick tips’ for preparing for an inspection? 1.03K viewsFDA 0 Votes 1 Ans Are we required to keep paper documents if we transcribe them into eCRFs? 994 viewsFDA 0 Votes 1 Ans Does the Investigator reply directly to a 483 or Warning Letter, or is it done through the sponsor since some of the observations might be the sponsor’s obligation? 1.08K viewsFDA 0 Votes 1 Ans When determining whether a lawfully marketed drug is IND exempt, is the IRB to evaluate only the current study, or any potential uses by the sponsor in the future? 1.22K viewsFDA 0 Votes 1 Ans When is an IND not needed for off-label use of an approved drug? 1.03K viewsFDA 0 Votes 1 Ans Who has the final determination for an IND exemption? I was told that even the PI feels the study meet all the exemption criteria, he/she still should contact the FDA to let FDA make the final determination. Is that correct, or can the IRB and PI make the determination without contacting the FDA? 1.25K viewsFDA 0 Votes 1 Ans What is 21 CFR 820 and what is ISO 13485:2003 1.10K viewsFDA 0 Votes 1 Ans Who is covered by 21 CFR 820 and who is covered by ISO 13485? 868 viewsFDA 0 Votes 1 Ans What’s the relationship between 21 CFR 820 and ISO 13485? 1.03K viewsFDA 0 Votes 1 Ans Who enforces 21 CFR 820 and ISO 13485? 1.23K viewsFDA 0 Votes 1 Ans What’s the connection between 21 CFR 820, ISO 13485, and MasterControl? 1.22K viewsFDA « Previous 1 2 … 46 47 48 49 50 … 75 76 Next » Question and answer is powered by anspress.net
