Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans When is an IND not needed for off-label use of an approved drug? 1.30K 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? 1.50K viewsFDA 0 Votes 1 Ans What is 21 CFR 820 and what is ISO 13485:2003 1.22K viewsFDA 0 Votes 1 Ans Who is covered by 21 CFR 820 and who is covered by ISO 13485? 1.11K viewsFDA 0 Votes 1 Ans What’s the relationship between 21 CFR 820 and ISO 13485? 1.20K viewsFDA 0 Votes 1 Ans Who enforces 21 CFR 820 and ISO 13485? 1.43K viewsFDA 0 Votes 1 Ans What’s the connection between 21 CFR 820, ISO 13485, and MasterControl? 1.34K viewsFDA 0 Votes 1 Ans What are the factors that determine whether the FDA will conduct a pre-announced or an unannounced inspection? 1.14K viewsFDA 0 Votes 1 Ans Do all pharmaceutical companies get inspected at some point? 1.14K viewsFDA 0 Votes 1 Ans What are the top three things that an FDA investigator looks for during a GMP inspection and why? 1.32K viewsFDA 0 Votes 1 Ans What are some of the most common reasons why companies get a Form FDA-483? 1.30K viewsFDA 0 Votes 1 Ans What are the things that FDA investigators look for in terms of training, training control, and training documentation? 1.36K viewsFDA 0 Votes 1 Ans How do you evaluate training? How can you tell if a company is in compliance with training requirements? 1.00K viewsFDA 0 Votes 1 Ans How do you evaluate training? How can you tell if a company is in compliance with training requirements? 1.20K viewsFDA 0 Votes 1 Ans What are the things that FDA investigators look for in terms of a company’s CAPA process? 1.16K viewsFDA 0 Votes 1 Ans What’s your advice to companies that are preparing for an FDA inspection — let’s say, a post-approval (CGMP) inspection? 1.50K viewsFDA 0 Votes 1 Ans What does FDA consider to be raw data? 1.26K viewsFDA 0 Votes 1 Ans What is the FDA’s objective when conducting a Sponsor/Monitor inspection? 1.37K viewsFDA 0 Votes 1 Ans How does FDA expect sponsors to handle protocol deviations and non-compliance issues at clinical sites? 1.27K viewsFDA 0 Votes 1 Ans Is the FDA focusing on computerized systems more during Sponsor/Monitor inspections? 1.26K viewsFDA « Previous 1 2 … 182 183 184 185 186 … 283 284 Next » Question and answer is powered by anspress.net
