Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans If a fatal flaw has not been identified, can the Agency issue a CR letter without inspections information? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans Whom does FDA consider as a packager for purposes of self-identification? 921 viewsDrugsPharmaceutical 0 Votes 1 Ans Who should self-identify as a repackager? 1.38K viewsDrugsPharmaceutical 0 Votes 1 Ans Are contract sterilizers required to self-identify? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans Are facilities that manufacture atypical APIs required to self-identify? 1.15K 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? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans If a manufacturer submits a change being effected (CBE) supplement, will FDA convert the supplement to a PAS? 855 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? 784 viewsDrugsPharmaceutical 0 Votes 1 Ans How will a refuse to receive decision for failure to pay facility fees affect the submission receipt date? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans Will priority be given to certain ANDAs under GDUFA? If so, what applications will be expedited? 1.26K viewsDrugsPharmaceutical 0 Votes 1 Ans How does GDUFA affect FDA’s refuse to receive policy? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans When will easily correctable deficiencies be communicated to sponsors? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans What is meant by tier type in the context of amendments to ANDAs and PASs? 1.01K 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? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to shred GMP related documents? 1.32K viewsDrugsPharmaceutical 0 Votes 1 Ans What about excess printouts from an HPLC because the printer failed? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans How soon after completion of a manufacturing step should a batch record be signed off by the reviewer? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it ok to correct an error in a record with initials and date? 1.04K viewsDrugsPharmaceutical 0 Votes 1 Ans Do we have to review the audit trail for every batch before release? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans Are paper based systems less susceptible to manipulation than computerized systems? 931 viewsDrugsPharmaceutical « Previous 1 2 … 27 28 29 30 31 … 79 80 Next » Question and answer is powered by anspress.net
