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
Inbox Filters
600 items match filters.
Correspondence List
Information request: manufacturing process change justification
FDA · FDA-2024-0001
MediumCompleted
Request for updated SmPC section 4.1
EMA · EMA-2023-0002
MediumDraft
GMP inspection findings clarification
PMDA · PMDA-2022-0003
HighCompleted
Request for post-marketing commitment progress update
NMPA · NMPA-2021-0004
MediumCompleted
Information request: manufacturing process change justification
ANVISA · ANVISA-2020-0005
HighDraft
Deficiency: inadequate paediatric data justification
HC · HC-2024-0006
LowDraft
Query regarding bioequivalence study design
TGA · TGA-2023-0007
LowCompleted
Request for additional clinical data on primary endpoint
MHRA · MHRA-2022-0008
MediumIn Progress
Query regarding bioequivalence study design
SwissMedic · SwissMedic-2021-0009
MediumOpen
Request for benefit-risk assessment addendum
MFDS · MFDS-2020-0010
LowIn Progress
Query regarding bioequivalence study design
TFDA · TFDA-2024-0011
LowOverdue
Request for updated SmPC section 4.1
HSA · HSA-2023-0012
HighIn Progress
Query: container closure integrity study methodology
CDSCO · CDSCO-2022-0013
LowIn Progress
Deficiency letter: missing stability data for 40°C condition
COFEPRIS · COFEPRIS-2021-0014
MediumDraft
Query: container closure integrity study methodology
ANMAT · ANMAT-2020-0015
MediumOverdue
Request for updated SmPC section 4.1
TITCK · TITCK-2024-0016
HighOverdue
Question on comparative dissolution data
SFDA · SFDA-2023-0017
HighOverdue
Query: container closure integrity study methodology
SAHPRA · SAHPRA-2022-0018
MediumDraft
Request for additional clinical data on primary endpoint
Roszdravnadzor · Roszdravnadzor-2021-0019
MediumOverdue
Query: container closure integrity study methodology
MOH-IL · MOH-IL-2020-0020
HighCompleted
Request for updated SmPC section 4.1
FDA · FDA-2024-0021
MediumIn Progress
Question on comparative dissolution data
EMA · EMA-2023-0022
LowOpen
Deficiency: inadequate paediatric data justification
PMDA · PMDA-2022-0023
MediumCompleted
Request for additional clinical data on primary endpoint
NMPA · NMPA-2021-0024
MediumOverdue
Request for updated SmPC section 4.1
ANVISA · ANVISA-2020-0025
LowDraft
Request for post-marketing commitment progress update
HC · HC-2024-0026
HighIn Progress
Question on comparative dissolution data
TGA · TGA-2023-0027
MediumOpen
Request for post-marketing commitment progress update
MHRA · MHRA-2022-0028
MediumOpen
Question on comparative dissolution data
SwissMedic · SwissMedic-2021-0029
MediumCompleted
Query regarding bioequivalence study design
MFDS · MFDS-2020-0030
MediumOpen
Request for post-marketing commitment progress update
TFDA · TFDA-2024-0031
LowCompleted
Request for updated SmPC section 4.1
HSA · HSA-2023-0032
HighOpen
Query regarding bioequivalence study design
CDSCO · CDSCO-2022-0033
LowDraft
Deficiency letter: missing stability data for 40°C condition
COFEPRIS · COFEPRIS-2021-0034
LowDraft
Information request: extractables and leachables data
ANMAT · ANMAT-2020-0035
MediumOpen
Deficiency: inadequate paediatric data justification
TITCK · TITCK-2024-0036
MediumOverdue
Deficiency letter: missing stability data for 40°C condition
SFDA · SFDA-2023-0037
MediumOpen
Request for benefit-risk assessment addendum
SAHPRA · SAHPRA-2022-0038
MediumOpen
Information request: manufacturing process change justification
Roszdravnadzor · Roszdravnadzor-2021-0039
LowCompleted
Request for benefit-risk assessment addendum
MOH-IL · MOH-IL-2020-0040
HighOpen
Request for additional clinical data on primary endpoint
FDA · FDA-2024-0041
MediumCompleted
Query regarding bioequivalence study design
EMA · EMA-2023-0042
MediumCompleted
Request for additional clinical data on primary endpoint
PMDA · PMDA-2022-0043
LowCompleted
Query: container closure integrity study methodology
NMPA · NMPA-2021-0044
MediumDraft
Query regarding bioequivalence study design
ANVISA · ANVISA-2020-0045
MediumOpen
Request for additional clinical data on primary endpoint
HC · HC-2024-0046
LowOpen
Request for additional clinical data on primary endpoint
TGA · TGA-2023-0047
LowIn Progress
Information request: manufacturing process change justification
MHRA · MHRA-2022-0048
MediumOverdue
Question on comparative dissolution data
SwissMedic · SwissMedic-2021-0049
MediumOpen
GMP inspection findings clarification
MFDS · MFDS-2020-0050
LowOpen
Request for additional clinical data on primary endpoint
TFDA · TFDA-2024-0051
MediumCompleted
Request for benefit-risk assessment addendum
HSA · HSA-2023-0052
MediumOpen
GMP inspection findings clarification
CDSCO · CDSCO-2022-0053
MediumOpen
Request for post-marketing commitment progress update
COFEPRIS · COFEPRIS-2021-0054
HighOpen
Question on comparative dissolution data
ANMAT · ANMAT-2020-0055
LowIn Progress
Deficiency letter: missing stability data for 40°C condition
TITCK · TITCK-2024-0056
MediumCompleted
Deficiency letter: missing stability data for 40°C condition
SFDA · SFDA-2023-0057
LowOverdue
Query regarding bioequivalence study design
SAHPRA · SAHPRA-2022-0058
HighIn Progress
Query: container closure integrity study methodology
Roszdravnadzor · Roszdravnadzor-2021-0059
MediumDraft
Deficiency letter: missing stability data for 40°C condition
MOH-IL · MOH-IL-2020-0060
HighOpen
Information request: extractables and leachables data
FDA · FDA-2024-0061
MediumCompleted
Deficiency letter: missing stability data for 40°C condition
EMA · EMA-2023-0062
HighIn Progress
Deficiency letter: missing stability data for 40°C condition
PMDA · PMDA-2022-0063
MediumDraft
Request for benefit-risk assessment addendum
NMPA · NMPA-2021-0064
MediumCompleted
Request for additional clinical data on primary endpoint
ANVISA · ANVISA-2020-0065
LowOpen
Information request: manufacturing process change justification
HC · HC-2024-0066
MediumIn Progress
Request for additional clinical data on primary endpoint
TGA · TGA-2023-0067
MediumDraft
Information request: extractables and leachables data
MHRA · MHRA-2022-0068
MediumOpen
Request for updated SmPC section 4.1
SwissMedic · SwissMedic-2021-0069
LowOverdue
GMP inspection findings clarification
MFDS · MFDS-2020-0070
LowCompleted
Question on comparative dissolution data
TFDA · TFDA-2024-0071
LowOpen
Question on comparative dissolution data
HSA · HSA-2023-0072
MediumIn Progress
Request for post-marketing commitment progress update
CDSCO · CDSCO-2022-0073
MediumCompleted
Request for benefit-risk assessment addendum
COFEPRIS · COFEPRIS-2021-0074
HighOverdue
Information request: manufacturing process change justification
ANMAT · ANMAT-2020-0075
MediumCompleted
Deficiency letter: missing stability data for 40°C condition
TITCK · TITCK-2024-0076
LowOpen
Request for post-marketing commitment progress update
SFDA · SFDA-2023-0077
MediumDraft
Query regarding bioequivalence study design
SAHPRA · SAHPRA-2022-0078
MediumOpen
Information request: extractables and leachables data
Roszdravnadzor · Roszdravnadzor-2021-0079
MediumOverdue
Deficiency letter: missing stability data for 40°C condition
MOH-IL · MOH-IL-2020-0080
MediumCompleted
Request for additional clinical data on primary endpoint
FDA · FDA-2024-0081
LowOpen
Request for benefit-risk assessment addendum
EMA · EMA-2023-0082
HighOpen
Request for updated SmPC section 4.1
PMDA · PMDA-2022-0083
MediumCompleted
Information request: manufacturing process change justification
NMPA · NMPA-2021-0084
HighIn Progress
Information request: extractables and leachables data
ANVISA · ANVISA-2020-0085
HighCompleted
GMP inspection findings clarification
HC · HC-2024-0086
LowIn Progress
Request for post-marketing commitment progress update
TGA · TGA-2023-0087
MediumDraft
Deficiency letter: missing stability data for 40°C condition
MHRA · MHRA-2022-0088
HighOpen
Request for benefit-risk assessment addendum
SwissMedic · SwissMedic-2021-0089
MediumDraft
Deficiency letter: missing stability data for 40°C condition
MFDS · MFDS-2020-0090
MediumOpen
Information request: manufacturing process change justification
TFDA · TFDA-2024-0091
MediumOpen
Information request: manufacturing process change justification
HSA · HSA-2023-0092
MediumDraft
Request for post-marketing commitment progress update
CDSCO · CDSCO-2022-0093
MediumOpen
Request for updated SmPC section 4.1
COFEPRIS · COFEPRIS-2021-0094
MediumOverdue
Deficiency letter: missing stability data for 40°C condition
ANMAT · ANMAT-2020-0095
HighCompleted
Information request: manufacturing process change justification
TITCK · TITCK-2024-0096
MediumCompleted
GMP inspection findings clarification
SFDA · SFDA-2023-0097
MediumCompleted
Deficiency letter: missing stability data for 40°C condition
SAHPRA · SAHPRA-2022-0098
MediumOpen
Question on comparative dissolution data
Roszdravnadzor · Roszdravnadzor-2021-0099
MediumIn Progress
Request for post-marketing commitment progress update
MOH-IL · MOH-IL-2020-0100
MediumIn Progress
Query regarding bioequivalence study design
FDA · FDA-2024-0001
MediumDraft
Request for benefit-risk assessment addendum
EMA · EMA-2023-0002
MediumOverdue
Query regarding bioequivalence study design
PMDA · PMDA-2022-0003
LowOverdue
Deficiency letter: missing stability data for 40°C condition
NMPA · NMPA-2021-0004
MediumDraft
Deficiency: inadequate paediatric data justification
ANVISA · ANVISA-2020-0005
MediumIn Progress
Deficiency letter: missing stability data for 40°C condition
HC · HC-2024-0006
HighDraft
Request for additional clinical data on primary endpoint
TGA · TGA-2023-0007
MediumCompleted
Request for updated SmPC section 4.1
MHRA · MHRA-2022-0008
LowOpen
Query regarding bioequivalence study design
SwissMedic · SwissMedic-2021-0009
LowDraft
Request for benefit-risk assessment addendum
MFDS · MFDS-2020-0010
HighDraft
Request for benefit-risk assessment addendum
TFDA · TFDA-2024-0011
HighDraft
Request for updated SmPC section 4.1
HSA · HSA-2023-0012
LowOpen
Request for updated SmPC section 4.1
CDSCO · CDSCO-2022-0013
MediumOpen
Request for post-marketing commitment progress update
COFEPRIS · COFEPRIS-2021-0014
MediumCompleted
Request for post-marketing commitment progress update
ANMAT · ANMAT-2020-0015
HighCompleted
Question on comparative dissolution data
TITCK · TITCK-2024-0016
MediumDraft
Request for post-marketing commitment progress update
SFDA · SFDA-2023-0017
LowCompleted
Request for benefit-risk assessment addendum
SAHPRA · SAHPRA-2022-0018
MediumDraft
Question on comparative dissolution data
Roszdravnadzor · Roszdravnadzor-2021-0019
LowIn Progress
Question on comparative dissolution data
MOH-IL · MOH-IL-2020-0020
HighIn Progress
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