Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans What should sponsors consider when deciding to validate outsourced electronic services that are used in clinical investigations? 1.91K viewsClinical Research 0 Votes 1 Ans Does FDA consider the mobile technology to contain the source data? 1.72K viewsClinical Research 0 Votes 1 Ans What should sponsors consider when implementing audit trails on data obtained directly from study participants using the mobile technology in the clinical investigation? 1.83K viewsClinical Research 0 Votes 1 Ans Why are only limited services available to process, store, or transmit PHI? 1.62K viewsHospital and Healthcare 0 Votes 1 Ans Whom does FDA consider as a packager for purposes of self-identification? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans Who should self-identify as a repackager? 1.67K viewsDrugsPharmaceutical 0 Votes 1 Ans Are contract sterilizers required to self-identify? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans Are facilities that manufacture atypical APIs required to self-identify? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans Will the failure of a site or organization referred to in an ANDA to self identify result in a delay in review or approval of that ANDA? 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans If a manufacturer submits a change being effected (CBE) supplement, will FDA convert the supplement to a PAS? 978 viewsDrugsPharmaceutical 0 Votes 1 Ans How does FDA determine the date and time of submission when a generic drug submission or Type II DMF is sent electronically? 934 viewsDrugsPharmaceutical 0 Votes 1 Ans How will a refuse to receive decision for failure to pay facility fees affect the submission receipt date? 1.32K viewsDrugsPharmaceutical 0 Votes 1 Ans Will priority be given to certain ANDAs under GDUFA? If so, what applications will be expedited? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans How does GDUFA affect FDA’s refuse to receive policy? 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans When will easily correctable deficiencies be communicated to sponsors? 1.56K viewsDrugsPharmaceutical 0 Votes 1 Ans What is meant by tier type in the context of amendments to ANDAs and PASs? 1.15K viewsDrugsPharmaceutical 0 Votes 1 Ans Will ANDA goal dates be adjusted if a sponsor submits an amendment that requires an inspection or identifies a major application change? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to shred GMP related documents? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans What about excess printouts from an HPLC because the printer failed? 1.35K viewsDrugsPharmaceutical 0 Votes 1 Ans How soon after completion of a manufacturing step should a batch record be signed off by the reviewer? 1.35K viewsDrugsPharmaceutical « Previous 1 2 … 115 116 117 118 119 … 283 284 Next » Question and answer is powered by anspress.net
