Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Will covered facilities need to submit their written food safety plans to FDA in advance of an inspection? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans Does FSMA expand the traceability requirements for food? 1.04K viewsDrugsPharmaceutical 0 Votes 1 Ans Will covered facilities be required to have supplier verification and approval programs? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans When will FDA complete its FSMA-related rulemakings? And when will covered facilities/entities need to comply with the requirements? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans How should the integrity of sterilising filters be verified? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the sampling requirements for sterility testing when a finished product batch of a terminally sterilised medicinal product is made up of more than one steriliser load? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans Who is responsible for performing cGMP Compliance Audits in a cGMP-licensed facility? 1.33K viewsDrugsPharmaceutical 0 Votes 1 Ans Why perform cGMP Compliance Audit in a cGMP-licensed facility? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans What types of facilities are covered by FSMA? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans Does FSMA cover farms? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans What about transporters like trucking firms, barge operators and railroads? Are they covered by FSMA? 1.35K viewsDrugsPharmaceutical 0 Votes 1 Ans Will small companies be exempt from FSMA requirements? 1.35K viewsDrugsPharmaceutical 0 Votes 1 Ans Doesn’t FSMA contain language that exempts facilities that only store and distribute grains and oilseeds from the hazard analysis and preventive controls requirements? 927 viewsDrugsPharmaceutical 0 Votes 1 Ans Will ANDA goal dates be adjusted if a sponsor submits a Tier 2 unsolicited amendment in the period between FDA’s issuance of a CR letter and the sponsor’s submission of its CR response? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the consequences for failure to pay the DMF fee? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans Will GDUFA goal dates apply if a facility identified in an ANDA fails to selfidentify during annual reporting period(s)? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the process for requesting a teleconference to clarify deficiencies and answer questions following FDA’s issuance of a CR letter? 1.22K viewsDrugsPharmaceutical 0 Votes 1 Ans Will FDA continue to accept applications in paper format? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans What does risk-adjusted parity mean? 1.26K viewsDrugsPharmaceutical 0 Votes 1 Ans What is a fatal flaw? 1.20K viewsDrugsPharmaceutical « Previous 1 2 … 26 27 28 29 30 … 79 80 Next » Question and answer is powered by anspress.net
