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? 1.53K 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? 1.70K viewsFDA 0 Votes 1 Ans What is 21 CFR 820 and what is ISO 13485:2003 1.36K viewsFDA 0 Votes 1 Ans Who is covered by 21 CFR 820 and who is covered by ISO 13485? 1.36K viewsFDA 0 Votes 1 Ans What’s the relationship between 21 CFR 820 and ISO 13485? 1.39K viewsFDA 0 Votes 1 Ans Who enforces 21 CFR 820 and ISO 13485? 1.62K viewsFDA 0 Votes 1 Ans What’s the connection between 21 CFR 820, ISO 13485, and MasterControl? 1.48K viewsFDA 0 Votes 1 Ans What are the factors that determine whether the FDA will conduct a pre-announced or an unannounced inspection? 1.29K viewsFDA 0 Votes 1 Ans Do all pharmaceutical companies get inspected at some point? 1.30K viewsFDA 0 Votes 1 Ans What are the top three things that an FDA investigator looks for during a GMP inspection and why? 1.47K viewsFDA 0 Votes 1 Ans What are some of the most common reasons why companies get a Form FDA-483? 1.44K viewsFDA 0 Votes 1 Ans What are the things that FDA investigators look for in terms of training, training control, and training documentation? 1.51K viewsFDA 0 Votes 1 Ans How do you evaluate training? How can you tell if a company is in compliance with training requirements? 1.14K viewsFDA 0 Votes 1 Ans How do you evaluate training? How can you tell if a company is in compliance with training requirements? 1.34K viewsFDA 0 Votes 1 Ans What are the things that FDA investigators look for in terms of a company’s CAPA process? 1.30K 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? 1.71K viewsFDA 0 Votes 1 Ans What does FDA consider to be raw data? 1.40K viewsFDA 0 Votes 1 Ans What is the FDA’s objective when conducting a Sponsor/Monitor inspection? 1.58K viewsFDA 0 Votes 1 Ans How does FDA expect sponsors to handle protocol deviations and non-compliance issues at clinical sites? 1.41K viewsFDA 0 Votes 1 Ans Is the FDA focusing on computerized systems more during Sponsor/Monitor inspections? 1.41K viewsFDA « Previous 1 2 … 182 183 184 185 186 … 283 284 Next » Question and answer is powered by anspress.net
