|
What steps is FDA taking or planing to take, to collaborate with other regulatory authorities to align on expectations for Step 2 confirmatory testing?
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4
|
294
|
July 28, 2021
|
|
Determining structural similarity for read-across
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|
2
|
248
|
July 8, 2021
|
|
Residual amines and risk assessment - how far do you go?
|
|
2
|
454
|
July 4, 2021
|
|
Are all N-nitrosamines a concern?
|
|
2
|
510
|
June 24, 2021
|
|
Nitrosamine Risk on shared equipment?
|
|
2
|
189
|
June 23, 2021
|
|
How ID all conditions and mechanism of Nitrosamine formations?
|
|
2
|
215
|
June 21, 2021
|
|
USP <1469> goes live Today
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|
3
|
270
|
June 16, 2021
|
|
Managing The Risk of Nitrosamine Impurities
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|
0
|
236
|
June 7, 2021
|
|
How to use Purge in Nitrosamine Risk Assessment?
|
|
7
|
472
|
May 26, 2021
|
|
How to do risk assessment in case of multi product facility of API considering cross contaminations?
|
|
0
|
237
|
May 26, 2021
|
|
Risk Assessment & Q(SAR)
|
|
2
|
294
|
May 21, 2021
|
|
Risk Assessment checklist, is that enough?
|
|
0
|
488
|
May 12, 2021
|
|
FDA - Nitrosamine: Where are we now?
|
|
0
|
195
|
April 21, 2021
|
|
FDA Q&A on DMFs and drug substances
|
|
0
|
248
|
April 20, 2021
|