This view shows all authority questions, scientific queries, and deficiency letters that require a formal written response. Items are sorted by due date and risk classification. Use the correspondence detail page to assemble and submit response packages.

IDSubjectTypeApplicationAuthorityRiskDueStatusOwner
COR-001Information request: manufacturing process change …deficiencyFDA-2024-0001FDAMedium2025-02-24CompletedDmitri Volkov
COR-002Request for updated SmPC section 4.1…queryEMA-2023-0002EMAMedium2025-04-07DraftSarah Chen
COR-003GMP inspection findings clarification…questionPMDA-2022-0003PMDAHigh2025-01-21CompletedNadia Petrova
COR-005Information request: manufacturing process change …queryANVISA-2020-0005ANVISAHigh2025-03-31DraftAisha Okonkwo
COR-007Query regarding bioequivalence study design…deficiencyTGA-2023-0007TGALow2025-04-15CompletedMarcus Webb
COR-009Query regarding bioequivalence study design…questionSwissMedic-2021-0009SwissMedicMedium2025-01-03OpenTomoko Ikeda
COR-012Request for updated SmPC section 4.1…deficiencyHSA-2023-0012HSAHigh2025-01-17In ProgressCarlos Mendez
COR-013Query: container closure integrity study methodolo…questionCDSCO-2022-0013CDSCOLow2025-02-08In ProgressTomoko Ikeda
COR-015Query: container closure integrity study methodolo…queryANMAT-2020-0015ANMATMedium2025-01-06OverdueLieselotte van der Berg
COR-017Question on comparative dissolution data…deficiencySFDA-2023-0017SFDAHigh2025-01-19OverdueLieselotte van der Berg
COR-018Query: container closure integrity study methodolo…querySAHPRA-2022-0018SAHPRAMedium2025-01-05DraftDmitri Volkov
COR-019Request for additional clinical data on primary en…questionRoszdravnadzor-2021-0019RoszdravnadzorMedium2025-03-03OverdueAisha Okonkwo
COR-020Query: container closure integrity study methodolo…queryMOH-IL-2020-0020MOH-ILHigh2025-01-19CompletedMarcus Webb
COR-021Request for updated SmPC section 4.1…questionFDA-2024-0021FDAMedium2024-12-25In ProgressAisha Okonkwo
COR-022Question on comparative dissolution data…deficiencyEMA-2023-0022EMALow2025-03-14OpenMarcus Webb
COR-023Deficiency: inadequate paediatric data justificati…deficiencyPMDA-2022-0023PMDAMedium2024-12-12CompletedMarcus Webb
COR-024Request for additional clinical data on primary en…deficiencyNMPA-2021-0024NMPAMedium2025-04-06OverduePriya Sharma
COR-025Request for updated SmPC section 4.1…queryANVISA-2020-0025ANVISALow2024-12-26DraftJames O'Brien
COR-026Request for post-marketing commitment progress upd…questionHC-2024-0026HCHigh2025-02-18In ProgressSarah Chen
COR-027Question on comparative dissolution data…questionTGA-2023-0027TGAMedium2024-12-22OpenAisha Okonkwo
COR-028Request for post-marketing commitment progress upd…deficiencyMHRA-2022-0028MHRAMedium2025-01-09OpenAisha Okonkwo
COR-029Question on comparative dissolution data…deficiencySwissMedic-2021-0029SwissMedicMedium2024-12-12CompletedNadia Petrova
COR-031Request for post-marketing commitment progress upd…questionTFDA-2024-0031TFDALow2024-12-27CompletedPriya Sharma
COR-032Request for updated SmPC section 4.1…queryHSA-2023-0032HSAHigh2025-02-06OpenNadia Petrova
COR-033Query regarding bioequivalence study design…queryCDSCO-2022-0033CDSCOLow2025-03-10DraftMarcus Webb
COR-034Deficiency letter: missing stability data for 40°C…questionCOFEPRIS-2021-0034COFEPRISLow2025-03-14DraftAisha Okonkwo
COR-035Information request: extractables and leachables d…questionANMAT-2020-0035ANMATMedium2024-12-31OpenNadia Petrova
COR-040Request for benefit-risk assessment addendum…questionMOH-IL-2020-0040MOH-ILHigh2025-02-17OpenDmitri Volkov
COR-042Query regarding bioequivalence study design…deficiencyEMA-2023-0042EMAMedium2024-12-30CompletedCarlos Mendez
COR-043Request for additional clinical data on primary en…queryPMDA-2022-0043PMDALow2024-12-21CompletedJames O'Brien
COR-044Query: container closure integrity study methodolo…deficiencyNMPA-2021-0044NMPAMedium2025-02-22DraftMarcus Webb
COR-045Query regarding bioequivalence study design…queryANVISA-2020-0045ANVISAMedium2025-01-06OpenMarcus Webb
COR-046Request for additional clinical data on primary en…questionHC-2024-0046HCLow2025-03-09OpenDmitri Volkov
COR-047Request for additional clinical data on primary en…questionTGA-2023-0047TGALow2025-04-08In ProgressTomoko Ikeda
COR-048Information request: manufacturing process change …deficiencyMHRA-2022-0048MHRAMedium2025-01-11OverdueNadia Petrova
COR-049Question on comparative dissolution data…querySwissMedic-2021-0049SwissMedicMedium2025-03-10OpenLieselotte van der Berg
COR-051Request for additional clinical data on primary en…deficiencyTFDA-2024-0051TFDAMedium2025-03-20CompletedNadia Petrova
COR-053GMP inspection findings clarification…questionCDSCO-2022-0053CDSCOMedium2025-03-08OpenTomoko Ikeda
COR-055Question on comparative dissolution data…queryANMAT-2020-0055ANMATLow2024-12-27In ProgressAisha Okonkwo
COR-057Deficiency letter: missing stability data for 40°C…questionSFDA-2023-0057SFDALow2025-04-01OverdueCarlos Mendez
COR-058Query regarding bioequivalence study design…questionSAHPRA-2022-0058SAHPRAHigh2024-12-17In ProgressAisha Okonkwo
COR-059Query: container closure integrity study methodolo…deficiencyRoszdravnadzor-2021-0059RoszdravnadzorMedium2025-03-03DraftJames O'Brien
COR-064Request for benefit-risk assessment addendum…deficiencyNMPA-2021-0064NMPAMedium2025-04-25CompletedCarlos Mendez
COR-066Information request: manufacturing process change …deficiencyHC-2024-0066HCMedium2025-01-21In ProgressDmitri Volkov
COR-067Request for additional clinical data on primary en…questionTGA-2023-0067TGAMedium2025-01-23DraftNadia Petrova
COR-068Information request: extractables and leachables d…deficiencyMHRA-2022-0068MHRAMedium2024-12-23OpenAisha Okonkwo
COR-071Question on comparative dissolution data…questionTFDA-2024-0071TFDALow2025-01-03OpenAisha Okonkwo
COR-073Request for post-marketing commitment progress upd…questionCDSCO-2022-0073CDSCOMedium2025-03-05CompletedDmitri Volkov
COR-075Information request: manufacturing process change …questionANMAT-2020-0075ANMATMedium2025-04-07CompletedLieselotte van der Berg
COR-081Request for additional clinical data on primary en…deficiencyFDA-2024-0081FDALow2025-03-19OpenJames O'Brien
COR-083Request for updated SmPC section 4.1…queryPMDA-2022-0083PMDAMedium2025-04-08CompletedCarlos Mendez
COR-084Information request: manufacturing process change …deficiencyNMPA-2021-0084NMPAHigh2025-05-06In ProgressJames O'Brien
COR-085Information request: extractables and leachables d…questionANVISA-2020-0085ANVISAHigh2025-04-13CompletedTomoko Ikeda
COR-086GMP inspection findings clarification…questionHC-2024-0086HCLow2025-04-09In ProgressAisha Okonkwo
COR-087Request for post-marketing commitment progress upd…questionTGA-2023-0087TGAMedium2025-04-14DraftPriya Sharma
COR-088Deficiency letter: missing stability data for 40°C…questionMHRA-2022-0088MHRAHigh2025-03-31OpenAisha Okonkwo
COR-090Deficiency letter: missing stability data for 40°C…deficiencyMFDS-2020-0090MFDSMedium2024-12-31OpenJames O'Brien
COR-091Information request: manufacturing process change …questionTFDA-2024-0091TFDAMedium2024-12-15OpenJames O'Brien
COR-092Information request: manufacturing process change …queryHSA-2023-0092HSAMedium2024-12-10DraftNadia Petrova
COR-093Request for post-marketing commitment progress upd…questionCDSCO-2022-0093CDSCOMedium2025-03-06OpenAisha Okonkwo