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Guideline ANVISA - Brazil: version 3, updates
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8
|
2681
|
June 19, 2023
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|
FDA solicit comments on assessment of NDSRIs
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12
|
1807
|
July 11, 2023
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Formation of N-nitroso Fluconazole and Related Triazole-Imidazole APIs
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4
|
844
|
June 9, 2023
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The predecesor to ICH M7
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0
|
507
|
June 7, 2023
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Secondary amine Risk Assessment
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9
|
968
|
June 1, 2023
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Nitrosamine in Peptides
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2
|
630
|
May 26, 2023
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Indian Pharmacopoeia introduces a new General Chapter on Nitrosamine Impurities in its 2022 edition
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4
|
1273
|
May 6, 2023
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IPEC India survey on excipients
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0
|
327
|
May 5, 2023
|
|
ECHA has provided Occupational Exposure Limit (OEL) values for most commonly used nitrosamines
|
|
0
|
524
|
April 27, 2023
|
|
Health Canada: Guidance on Nitrosamine Impurities in Medications
|
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0
|
1001
|
April 23, 2023
|
|
EMA Nitrosamine Q&A Rev15 published
|
|
12
|
2286
|
April 18, 2023
|
|
3-year work plan for EMA Nitrosamine Safety Operational Expert Group
|
|
0
|
460
|
March 11, 2023
|
|
Health Canada - Guideline: Quality (CMC) Draft Guidance - New Drug Submissions & Abbreviated New Drug Submissions
|
|
0
|
869
|
February 27, 2023
|
|
FDA updated compliance program guidance por inspections
|
|
1
|
582
|
February 27, 2023
|
|
👋🏻 Fantastic Regulatory Update Europe, US, LATAM
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8
|
1970
|
February 25, 2023
|
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EMA Nitrosamine Q&A Rev14 published
|
|
6
|
1189
|
February 23, 2023
|
|
Fourth Nitrosamine Implementation Oversight Group (NIOG) meeting
|
|
4
|
1034
|
February 16, 2023
|
|
European Pharmacopoeia Activities on Control of Nitrosamines and other DNA-Reactive Impurities
|
|
4
|
452
|
February 15, 2023
|
|
The research article published by several industry colleagues
|
|
1
|
619
|
February 9, 2023
|
|
Swissmedic - Applicant's consent for sharing risk assessments info
|
|
0
|
350
|
January 10, 2023
|
|
FDA Guidance - Controlled Correspondence Related to Generic Drug Development
|
|
0
|
307
|
December 21, 2022
|
|
EFPIA workflows for quality risk management of nitrosamine risks in medicines (ver 2.0)
|
|
3
|
1213
|
December 19, 2022
|
|
Nitrosamines & others- Cosmetics - Inditex report
|
|
0
|
229
|
December 19, 2022
|
|
EMA Nitrosamine Q&A Rev13 published
|
|
9
|
548
|
December 15, 2022
|
|
The revision history of EMA's nitrosamine Q&A
|
|
9
|
905
|
December 14, 2022
|
|
Contamination of drugs with nitrosamines: health risks and drug recalls in Brazil
|
|
2
|
580
|
November 24, 2022
|
|
AMES test modifications FDA & EMA instructions
|
|
4
|
621
|
November 24, 2022
|
|
Nitrite / Nitrosamine levels in Excipients
|
|
0
|
434
|
November 17, 2022
|
|
EMA Nitrosamines Q&A Rev 12 (10 OCT 2022) - Temporary AI limit
|
|
6
|
1193
|
October 20, 2022
|
|
WHO Revision on Rafampicin Monograph and Test Method
|
|
0
|
283
|
October 19, 2022
|