Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Do the labeling requirements for nutrient content claims apply to medical foods? 1.03K viewsFDA 0 Votes 1 Ans Do the labeling requirements for health claims apply to medical foods? 1.21K viewsFDA 0 Votes 1 Ans What labeling requirements apply to medical foods? 1.13K viewsFDA 0 Votes 1 Ans What other FDA requirements apply to medical foods? 1.36K viewsFDA 0 Votes 1 Ans Does the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) apply to medical foods? 1.09K viewsFDA 0 Votes 1 Ans What are the registration requirements for medical food facilities? 1.18K viewsFDA 0 Votes 1 Ans What is the purpose of FDA’s compliance program for medical foods? 945 viewsFDA 0 Votes 1 Ans Does FDA require that medical foods be made available by written or oral prescription? 902 viewsFDA 0 Votes 1 Ans What’s your advice to companies that receive a Form FDA-483? 1.14K viewsFDA 0 Votes 1 Ans What is the Good Tissue Practice? 1.23K viewsFDA 0 Votes 1 Ans What is Current Good Tissue Practice? 1.21K viewsFDA 0 Votes 1 Ans What are the CGTP Requirements? 988 viewsFDA 0 Votes 1 Ans How can MasterControl help tissue establishments facilitate GTP compliance? 1.03K viewsFDA 0 Votes 1 Ans Does the Principal Investigator (PI) have to be 100% available for the whole duration of the audit? 1.06K viewsFDA 0 Votes 1 Ans Do all staff members need to have Good Clinical Practice (GCP) and Human Subject Protection Training (HSP)? 1.10K viewsFDA 0 Votes 1 Ans What are some tips for clearly showing PI oversight of a study? 958 viewsFDA 0 Votes 1 Ans What are some ‘quick tips’ for preparing for an inspection? 1.07K viewsFDA 0 Votes 1 Ans Are we required to keep paper documents if we transcribe them into eCRFs? 1.04K 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? 1.12K 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? 1.30K viewsFDA « Previous 1 2 … 181 182 183 184 185 … 283 284 Next » Question and answer is powered by anspress.net
