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Sharan Murugan
- Oct 13, 2021
- 1 min
ICH guideline Recommendation on Daily (PDE) Limits for Seven Mutagenic Impurities
The International Council for Harmonization (ICH) Endorsed on 6 October 2021 its (Addendum to M7(R2)) M7(R2) draft guideline setting new...
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Sharan Murugan
- Oct 3, 2021
- 1 min
USFDA’s drafts “Benefit-Risk Assessment for New Drug and Biological Products” Guidance
The intent of this guidance is to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and...
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Sharan Murugan
- Oct 3, 2021
- 1 min
FDA’s finalized “Interpreting Sameness” Gene Therapy Products Guidance
USFDA on 29 September 2021, finalized "Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations". This guidance...
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Sharan Murugan
- Sep 23, 2021
- 1 min
USFDA finalizes Q&As on Biosimilar Development
US Food and Drug Administration on 17th September, 2021 finalized additional questions and answers related to biosimilar development and...
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Sharan Murugan
- Aug 8, 2021
- 1 min
Guidance’s on GMP for Investigational Products & for R&D facilities -WHO
World Health Organization (WHO) recently issued revised guidance to industry addressing good manufacturing practices (GMPs) for...
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