Bioequivalence and Bioavailability Forum • New product specific guidance of Fidaxomicin

New product specific guidance of Fidaxomicin [BE/BA News]

posted by Mahesh M – India, 2016-08-24 07:58 (3588 d 19:19 ago) – Posting: # 16564
Views: 15,137

Dear All,

Today FDA release new product specific guidance of Fidaxomicin please find below link for the same.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM517624.pdf

Regards

Complete thread:

EMA: 7 product-specific guidances adopted Helmut 2015-07-07 14:10
- EMA: 7 product-specific guidances adopted mittyri 2015-07-08 13:55
  - capecitabine ≠ NTID; reference-scaling Helmut 2015-07-08 14:59
- Tadalafil: Similar technology and formulas as the originator luvblooms 2015-07-10 07:24
  - Tadalafil: Similar technology and formulas as the originator mmw 2015-07-17 11:38
- 9 new just published Ohlbe 2016-04-07 19:08
- Five new drafts published Helmut 2016-08-23 15:09
  - New product specific guidance of FidaxomicinMahesh M 2016-08-24 05:58
- EMA: 7 product-specific guidances adopted (Capecitabine) Mauricio Sampaio 2016-12-12 19:33
  - Capecitabine: study with healthy volunteers mittyri 2016-12-14 12:39

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