|
European Pharmacopoeia Activities on Control of Nitrosamines and other DNA-Reactive Impurities
|
|
4
|
528
|
February 15, 2023
|
|
The research article published by several industry colleagues
|
|
1
|
737
|
February 9, 2023
|
|
Swissmedic - Applicant's consent for sharing risk assessments info
|
|
0
|
409
|
January 10, 2023
|
|
FDA Guidance - Controlled Correspondence Related to Generic Drug Development
|
|
0
|
384
|
December 21, 2022
|
|
EFPIA workflows for quality risk management of nitrosamine risks in medicines (ver 2.0)
|
|
3
|
1639
|
December 19, 2022
|
|
Nitrosamines & others- Cosmetics - Inditex report
|
|
0
|
306
|
December 19, 2022
|
|
EMA Nitrosamine Q&A Rev13 published
|
|
9
|
709
|
December 15, 2022
|
|
The revision history of EMA's nitrosamine Q&A
|
|
9
|
1106
|
December 14, 2022
|
|
Contamination of drugs with nitrosamines: health risks and drug recalls in Brazil
|
|
2
|
712
|
November 24, 2022
|
|
AMES test modifications FDA & EMA instructions
|
|
4
|
690
|
November 24, 2022
|
|
Nitrite / Nitrosamine levels in Excipients
|
|
0
|
526
|
November 17, 2022
|
|
EMA Nitrosamines Q&A Rev 12 (10 OCT 2022) - Temporary AI limit
|
|
6
|
1441
|
October 20, 2022
|
|
WHO Revision on Rafampicin Monograph and Test Method
|
|
0
|
363
|
October 19, 2022
|
|
Nitrosamine Impurities: Extension of the Deadline for the Submission of Variations
|
|
9
|
879
|
September 28, 2022
|
|
Swissmedic updates DMF submission form to include Nitrosamine Exchange information
|
|
1
|
467
|
September 25, 2022
|
|
The deadline for step2 in EMA is coming
|
|
2
|
438
|
September 23, 2022
|
|
Nitrosamines in Pharmaceuticals: Toxicity, Risk Analysis, Chemistry and Test Methods
|
|
0
|
589
|
September 22, 2022
|
|
Mutagenic Impurities and Potentially Mutagenic Impurities in the USP-NF
|
|
4
|
577
|
September 6, 2022
|
|
Health Canada Nitrosamine Guidance -Effective Sep 2022
|
|
0
|
914
|
September 5, 2022
|
|
What Goes Wrong When API Quality is Compromised?
|
|
1
|
362
|
August 13, 2022
|
|
Step 2: No Nitrosamine detected response template (updated)
|
|
0
|
328
|
August 12, 2022
|
|
Critical Analysis of Drug Product Recalls due to Nitrosamine Impurities
|
|
0
|
414
|
August 7, 2022
|
|
CMDh practical guidance for Marketing Authorisation Holders
|
|
0
|
525
|
August 3, 2022
|
|
Egyptian Drug Authority (EDA) Technical Consultation
|
|
1
|
364
|
July 28, 2022
|
|
SwissMedic - Applicant's consent to share Nitrosamine information
|
|
0
|
306
|
July 5, 2022
|
|
Third Nitrosamine Implementation Oversight Group (NIOG) - meeting with pharmaceutical industry
|
|
2
|
480
|
July 1, 2022
|
|
Guidance on Nitrosamine Impurities from Health Canada
|
|
6
|
422
|
June 3, 2022
|
|
Sept 2021 Revised QnA document from EMA
|
|
7
|
781
|
June 2, 2022
|
|
UPDATED - Health Canada - Q&A Document on Nitrosamine
|
|
1
|
720
|
June 1, 2022
|
|
ANVISA Ver 2- Guide for Controlling Nitrosamines in Active Pharmaceutical Ingredients and Medicines
|
|
1
|
1654
|
May 11, 2022
|