CMDh Practical guidance for Marketing Authorization Holders -Update questions
|
|
1
|
421
|
January 20, 2022
|
Metformin Recall mktd by Viona Pharmaceuticals Inc
|
|
4
|
415
|
January 20, 2022
|
Nitrosamine Implementation Oversight Group (NIOG) - second meeting with pharmaceutical industry
|
|
2
|
379
|
January 20, 2022
|
Should we expand to Analytical Category? need your feedback!
|
|
20
|
823
|
January 18, 2022
|
Is AZBT (azidomethyl-biphenyl-tetrazole) the new Nitrosamine?
|
|
6
|
1217
|
January 16, 2022
|
Nitrosamines Formation as Artefact... What are the Challenges?
|
|
11
|
728
|
December 22, 2021
|
Any experience on this structure?
|
|
7
|
567
|
December 20, 2021
|
AIs for Complex Nitrosamines by MW Adjustments, any experience?
|
|
4
|
623
|
December 16, 2021
|
Https://www.fda.gov/media/154487/download
|
|
0
|
307
|
December 8, 2021
|
Nitrosamine Workshop USP / Sindusfarma / ANF ACFB -live discussion
|
|
7
|
1062
|
December 8, 2021
|
Nitrosamine Impurities - Regulatory Status
|
|
0
|
307
|
December 7, 2021
|
USP- Approved <1469> Nitrosamines Impurities
|
|
1
|
1342
|
December 6, 2021
|
FDA currently published "Updates on possible mitigation strategies to reduce the risk of nitrosamine..."
|
|
2
|
566
|
November 26, 2021
|
AAM’s GRx+Biosims "Nitrosamines In Pharmaceuticals: Where the Industry and Agency Stands"
|
|
4
|
304
|
November 23, 2021
|
When minimum information is provided for risk assessment?
|
|
1
|
320
|
November 23, 2021
|
PhARMA - Global Workshop on Nitrosamine (Part II) *FREE*
|
|
5
|
516
|
November 23, 2021
|
PhARMA - Global Workshop on Nitrosamine -Report
|
|
1
|
485
|
November 23, 2021
|
Laboratory analysis of varenicline products by FDA
|
|
14
|
1151
|
November 23, 2021
|
Another azido impurity detected in losartan potassium, Ames test +
|
|
5
|
617
|
November 16, 2021
|
Referential Testing Methods by FDA's presentation
|
|
0
|
281
|
November 18, 2021
|
LATAM Nitrosamine 2 days Workshop -First of its kind!
|
|
3
|
418
|
November 17, 2021
|
FDA-published method for Rifampin & Rifapentine DS/DP
|
|
0
|
392
|
November 17, 2021
|
Health Canada - Urgent Public Health needed due Nitrosamine
|
|
1
|
295
|
November 16, 2021
|
Japan - What's next on Nitrosamine?
|
|
4
|
554
|
November 11, 2021
|
Malaysia 2nd Regulatory Seminar 23-24 Nov 2021
|
|
0
|
299
|
November 8, 2021
|
Nitrosamines at FDA's Pharmaceutical Quality Symposium 2021
|
|
0
|
284
|
October 27, 2021
|
FDA Webcast to report Investigation 'Ranitidine converts to a probable carcinogen in Human?'
|
|
4
|
286
|
October 27, 2021
|
Nitrosamine in Varenicline particularly Nitroso-varenicline
|
|
8
|
2156
|
October 14, 2021
|
NDMA Analytics in Metformin -Methods and Pitfalls?
|
|
0
|
375
|
October 18, 2021
|
Excipients, morpholine?
|
|
4
|
370
|
October 18, 2021
|