Correspondence
The correspondence inbox aggregates all authority communications including questions, queries, deficiency letters, commitment requests, and information requests. This operational view lets teams filter by authority, due date, risk, and status to prioritize responses before deadlines. Selecting an item reveals the linked application, owner, attachments, and response package context for controlled assembly. Use the workbench to move from inquiry triage to complete response package preparation without leaving the page.
Open
136
In Progress
116
Overdue
106
High Risk Open
103
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600 items match filters.
Correspondence List
Information request: manufacturing process change justification
FDA · FDA-2024-0001
Request for updated SmPC section 4.1
EMA · EMA-2023-0002
GMP inspection findings clarification
PMDA · PMDA-2022-0003
Request for post-marketing commitment progress update
NMPA · NMPA-2021-0004
Information request: manufacturing process change justification
ANVISA · ANVISA-2020-0005
Deficiency: inadequate paediatric data justification
HC · HC-2024-0006
Query regarding bioequivalence study design
TGA · TGA-2023-0007
Request for additional clinical data on primary endpoint
MHRA · MHRA-2022-0008
Query regarding bioequivalence study design
SwissMedic · SwissMedic-2021-0009
Request for benefit-risk assessment addendum
MFDS · MFDS-2020-0010
Query regarding bioequivalence study design
TFDA · TFDA-2024-0011
Request for updated SmPC section 4.1
HSA · HSA-2023-0012
Query: container closure integrity study methodology
CDSCO · CDSCO-2022-0013
Deficiency letter: missing stability data for 40°C condition
COFEPRIS · COFEPRIS-2021-0014
Query: container closure integrity study methodology
ANMAT · ANMAT-2020-0015
Request for updated SmPC section 4.1
TITCK · TITCK-2024-0016
Question on comparative dissolution data
SFDA · SFDA-2023-0017
Query: container closure integrity study methodology
SAHPRA · SAHPRA-2022-0018
Request for additional clinical data on primary endpoint
Roszdravnadzor · Roszdravnadzor-2021-0019
Query: container closure integrity study methodology
MOH-IL · MOH-IL-2020-0020
Request for updated SmPC section 4.1
FDA · FDA-2024-0021
Question on comparative dissolution data
EMA · EMA-2023-0022
Deficiency: inadequate paediatric data justification
PMDA · PMDA-2022-0023
Request for additional clinical data on primary endpoint
NMPA · NMPA-2021-0024
Request for updated SmPC section 4.1
ANVISA · ANVISA-2020-0025
Request for post-marketing commitment progress update
HC · HC-2024-0026
Question on comparative dissolution data
TGA · TGA-2023-0027
Request for post-marketing commitment progress update
MHRA · MHRA-2022-0028
Question on comparative dissolution data
SwissMedic · SwissMedic-2021-0029
Query regarding bioequivalence study design
MFDS · MFDS-2020-0030
Request for post-marketing commitment progress update
TFDA · TFDA-2024-0031
Request for updated SmPC section 4.1
HSA · HSA-2023-0032
Query regarding bioequivalence study design
CDSCO · CDSCO-2022-0033
Deficiency letter: missing stability data for 40°C condition
COFEPRIS · COFEPRIS-2021-0034
Information request: extractables and leachables data
ANMAT · ANMAT-2020-0035
Deficiency: inadequate paediatric data justification
TITCK · TITCK-2024-0036
Deficiency letter: missing stability data for 40°C condition
SFDA · SFDA-2023-0037
Request for benefit-risk assessment addendum
SAHPRA · SAHPRA-2022-0038
Information request: manufacturing process change justification
Roszdravnadzor · Roszdravnadzor-2021-0039
Request for benefit-risk assessment addendum
MOH-IL · MOH-IL-2020-0040
Request for additional clinical data on primary endpoint
FDA · FDA-2024-0041
Query regarding bioequivalence study design
EMA · EMA-2023-0042
Request for additional clinical data on primary endpoint
PMDA · PMDA-2022-0043
Query: container closure integrity study methodology
NMPA · NMPA-2021-0044
Query regarding bioequivalence study design
ANVISA · ANVISA-2020-0045
Request for additional clinical data on primary endpoint
HC · HC-2024-0046
Request for additional clinical data on primary endpoint
TGA · TGA-2023-0047
Information request: manufacturing process change justification
MHRA · MHRA-2022-0048
Question on comparative dissolution data
SwissMedic · SwissMedic-2021-0049
GMP inspection findings clarification
MFDS · MFDS-2020-0050
Request for additional clinical data on primary endpoint
TFDA · TFDA-2024-0051
Request for benefit-risk assessment addendum
HSA · HSA-2023-0052
GMP inspection findings clarification
CDSCO · CDSCO-2022-0053
Request for post-marketing commitment progress update
COFEPRIS · COFEPRIS-2021-0054
Question on comparative dissolution data
ANMAT · ANMAT-2020-0055
Deficiency letter: missing stability data for 40°C condition
TITCK · TITCK-2024-0056
Deficiency letter: missing stability data for 40°C condition
SFDA · SFDA-2023-0057
Query regarding bioequivalence study design
SAHPRA · SAHPRA-2022-0058
Query: container closure integrity study methodology
Roszdravnadzor · Roszdravnadzor-2021-0059
Deficiency letter: missing stability data for 40°C condition
MOH-IL · MOH-IL-2020-0060
Information request: extractables and leachables data
FDA · FDA-2024-0061
Deficiency letter: missing stability data for 40°C condition
EMA · EMA-2023-0062
Deficiency letter: missing stability data for 40°C condition
PMDA · PMDA-2022-0063
Request for benefit-risk assessment addendum
NMPA · NMPA-2021-0064
Request for additional clinical data on primary endpoint
ANVISA · ANVISA-2020-0065
Information request: manufacturing process change justification
HC · HC-2024-0066
Request for additional clinical data on primary endpoint
TGA · TGA-2023-0067
Information request: extractables and leachables data
MHRA · MHRA-2022-0068
Request for updated SmPC section 4.1
SwissMedic · SwissMedic-2021-0069
GMP inspection findings clarification
MFDS · MFDS-2020-0070
Question on comparative dissolution data
TFDA · TFDA-2024-0071
Question on comparative dissolution data
HSA · HSA-2023-0072
Request for post-marketing commitment progress update
CDSCO · CDSCO-2022-0073
Request for benefit-risk assessment addendum
COFEPRIS · COFEPRIS-2021-0074
Information request: manufacturing process change justification
ANMAT · ANMAT-2020-0075
Deficiency letter: missing stability data for 40°C condition
TITCK · TITCK-2024-0076
Request for post-marketing commitment progress update
SFDA · SFDA-2023-0077
Query regarding bioequivalence study design
SAHPRA · SAHPRA-2022-0078
Information request: extractables and leachables data
Roszdravnadzor · Roszdravnadzor-2021-0079
Deficiency letter: missing stability data for 40°C condition
MOH-IL · MOH-IL-2020-0080
Request for additional clinical data on primary endpoint
FDA · FDA-2024-0081
Request for benefit-risk assessment addendum
EMA · EMA-2023-0082
Request for updated SmPC section 4.1
PMDA · PMDA-2022-0083
Information request: manufacturing process change justification
NMPA · NMPA-2021-0084
Information request: extractables and leachables data
ANVISA · ANVISA-2020-0085
GMP inspection findings clarification
HC · HC-2024-0086
Request for post-marketing commitment progress update
TGA · TGA-2023-0087
Deficiency letter: missing stability data for 40°C condition
MHRA · MHRA-2022-0088
Request for benefit-risk assessment addendum
SwissMedic · SwissMedic-2021-0089
Deficiency letter: missing stability data for 40°C condition
MFDS · MFDS-2020-0090
Information request: manufacturing process change justification
TFDA · TFDA-2024-0091
Information request: manufacturing process change justification
HSA · HSA-2023-0092
Request for post-marketing commitment progress update
CDSCO · CDSCO-2022-0093
Request for updated SmPC section 4.1
COFEPRIS · COFEPRIS-2021-0094
Deficiency letter: missing stability data for 40°C condition
ANMAT · ANMAT-2020-0095
Information request: manufacturing process change justification
TITCK · TITCK-2024-0096
GMP inspection findings clarification
SFDA · SFDA-2023-0097
Deficiency letter: missing stability data for 40°C condition
SAHPRA · SAHPRA-2022-0098
Question on comparative dissolution data
Roszdravnadzor · Roszdravnadzor-2021-0099
Request for post-marketing commitment progress update
MOH-IL · MOH-IL-2020-0100
Query regarding bioequivalence study design
FDA · FDA-2024-0001
Request for benefit-risk assessment addendum
EMA · EMA-2023-0002
Query regarding bioequivalence study design
PMDA · PMDA-2022-0003
Deficiency letter: missing stability data for 40°C condition
NMPA · NMPA-2021-0004
Deficiency: inadequate paediatric data justification
ANVISA · ANVISA-2020-0005
Deficiency letter: missing stability data for 40°C condition
HC · HC-2024-0006
Request for additional clinical data on primary endpoint
TGA · TGA-2023-0007
Request for updated SmPC section 4.1
MHRA · MHRA-2022-0008
Query regarding bioequivalence study design
SwissMedic · SwissMedic-2021-0009
Request for benefit-risk assessment addendum
MFDS · MFDS-2020-0010
Request for benefit-risk assessment addendum
TFDA · TFDA-2024-0011
Request for updated SmPC section 4.1
HSA · HSA-2023-0012
Request for updated SmPC section 4.1
CDSCO · CDSCO-2022-0013
Request for post-marketing commitment progress update
COFEPRIS · COFEPRIS-2021-0014
Request for post-marketing commitment progress update
ANMAT · ANMAT-2020-0015
Question on comparative dissolution data
TITCK · TITCK-2024-0016
Request for post-marketing commitment progress update
SFDA · SFDA-2023-0017
Request for benefit-risk assessment addendum
SAHPRA · SAHPRA-2022-0018
Question on comparative dissolution data
Roszdravnadzor · Roszdravnadzor-2021-0019
Question on comparative dissolution data
MOH-IL · MOH-IL-2020-0020
Selected Detail
Question Text
Information request: manufacturing process change justification
Linked Application
Responsible Owner
Dmitri Volkov
Due Date
2025-02-24
Attachments
Response Package
Controlled content selection required before final response submission.
Open Content Assembly