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About the Guidance, Documents, Resources category
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0
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79
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April 14, 2021
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3-year work plan for EMA Nitrosamine Safety Operational Expert Group
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0
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139
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March 11, 2023
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FDA - Notice on Chantix
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2
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142
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March 1, 2023
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Health Canada - Guideline: Quality (CMC) Draft Guidance - New Drug Submissions & Abbreviated New Drug Submissions
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0
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138
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February 27, 2023
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FDA updated compliance program guidance por inspections
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1
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302
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February 27, 2023
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👋🏻 Fantastic Regulatory Update Europe, US, LATAM
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8
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774
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February 25, 2023
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EMA Nitrosamine Q&A Rev14 published
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6
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392
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February 23, 2023
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Fourth Nitrosamine Implementation Oversight Group (NIOG) meeting
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4
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410
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February 16, 2023
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European Pharmacopoeia Activities on Control of Nitrosamines and other DNA-Reactive Impurities
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4
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199
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February 15, 2023
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The research article published by several industry colleagues
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1
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231
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February 9, 2023
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Swissmedic - Applicant's consent for sharing risk assessments info
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0
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93
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January 10, 2023
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FDA Guidance - Controlled Correspondence Related to Generic Drug Development
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0
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89
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December 21, 2022
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APIC NA Risk Assessment Template
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3
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137
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December 19, 2022
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EFPIA workflows for quality risk management of nitrosamine risks in medicines (ver 2.0)
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3
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181
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December 19, 2022
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Nitrosamines & others- Cosmetics - Inditex report
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0
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58
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December 19, 2022
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EMA Nitrosamine Q&A Rev13 published
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9
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226
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December 15, 2022
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The revision history of EMA's nitrosamine Q&A
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9
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308
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December 14, 2022
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Contamination of drugs with nitrosamines: health risks and drug recalls in Brazil
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2
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239
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November 24, 2022
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AMES test modifications FDA & EMA instructions
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4
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270
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November 24, 2022
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Nitrite / Nitrosamine levels in Excipients
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0
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102
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November 17, 2022
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EMA Nitrosamines Q&A Rev 12 (10 OCT 2022) - Temporary AI limit
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6
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348
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October 20, 2022
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WHO Revision on Rafampicin Monograph and Test Method
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0
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74
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October 19, 2022
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Nitrosamine Impurities: Extension of the Deadline for the Submission of Variations
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9
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228
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September 28, 2022
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Swissmedic updates DMF submission form to include Nitrosamine Exchange information
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1
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156
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September 25, 2022
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The deadline for step2 in EMA is coming
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2
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132
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September 23, 2022
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Nitrosamines in Pharmaceuticals: Toxicity, Risk Analysis, Chemistry and Test Methods
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0
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211
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September 22, 2022
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Indian Pharmacopoeia introduces a new General Chapter on Nitrosamine Impurities in its 2022 edition
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3
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155
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September 14, 2022
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Mutagenic Impurities and Potentially Mutagenic Impurities in the USP-NF
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4
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179
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September 6, 2022
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Health Canada Nitrosamine Guidance -Effective Sep 2022
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0
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156
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September 5, 2022
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What Goes Wrong When API Quality is Compromised?
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1
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108
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August 13, 2022
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