Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans GCP sets out responsibilities for the sponsor and the investigator, but tasks are increasingly undertaken by a range of contractors – how should this situation be addressed? 1.60K viewsClinical Research 0 Votes 1 Ans Does the Inspectorate encourage the use of environmental isolates for preservative effectiveness testing? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans Should an inspector observe and question a technician’s analytical work? 1.06K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the official method DO-25 apply to tablets labelled as being professed or as manufacturer’s standard? 1.05K viewsDrugsPharmaceutical 0 Votes 1 Ans Do tests for impurities have to be repeated for finished products if they have been done on the raw materials? 1.22K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the minimum testing requirements for solid dosage drugs? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the standards other than the United States Pharmacopoeia (USP) that have official status in Canada? 1.15K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the format of the product list in CECATS? 1.65K viewsFDA 0 Votes 1 Ans Is there a limit to the number of attachment pages? What happens if my request is over 25 pages? CECATS 1.66K viewsFDA 0 Votes 1 Ans Does it matter which establishment is identified as the Primary Facility? CECATS 1.79K viewsFDA 0 Votes 1 Ans CECATS is asking me for a prepaid return shipping label. What does that mean? 1.61K viewsFDA 0 Votes 1 Ans How long will it take for FDA to process my request for a certificate? CECATS 1.74K viewsFDA 0 Votes 1 Ans How can I check on the status of my application? CECATS 1.76K viewsFDA 0 Votes 1 Ans What do I do in response to a Return for Action notification? CECATS 1.55K viewsFDA 0 Votes 1 Ans Why can’t changes be made to an application that is marked “Incomplete”? CECATS 1.89K viewsFDA 0 Votes 1 Ans Is there a CECATS fee to receive an export certificate? 1.84K viewsFDA 0 Votes 1 Ans Can I get additional certificates from CECATS? 1.44K viewsFDA 0 Votes 1 Ans I overheard one of the members of our medical staff say that investigatorinitiated drug studies are easier to manage because they are exempt from FDA regulations. Is it true that FDA requirements do not apply to investigator-initiated studies? 1.47K viewsClinical Research 0 Votes 1 Ans I am a principal investigator looking to sponsor a study that will investigate a new indication for a drug that has already been approved by the FDA. The manufacturer has agreed to provide the study drug to me free-of-charge and might fund the study as well. The sales representative said the company wants to send me, and my husband, on an all-expenses paid 10-day trip to Paris. They have an office there and have asked me to meet with company representatives to review my protocol. The company also wants me to meet other researchers based in Europe who are looking at new uses for the same drug; they think we should meet to discuss our respective protocols and share ideas, increase efficiencies, and perhaps collaborate rather than run separate studies. The meeting with the company representatives and the researchers will only take two days to complete. Is it OK to accept the free study drug, funding, and trip to Paris? 1.47K viewsClinical Research 0 Votes 1 Ans How does a research site maintain compliance with IRB approval requirements if patient recruitment content is included in a blog? 1.50K viewsClinical Research « Previous 1 2 … 138 139 140 141 142 … 283 284 Next » Question and answer is powered by anspress.net
