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Sharan Murugan
- Apr 20
- 2 min
WHO Guidance: GMP in Preventing and Controlling Nitrosamine Contamination in Pharmaceuticals
Earlier this week, the World Health Organization (WHO) released draft guidelines "WHO Good Manufacturing Practices Considerations for the...
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Sharan Murugan
- Dec 30, 2023
- 2 min
USFDA : CMC Guidance Reformulating Drug Products That Contain Carbomers & Potency Assurance for Cellular & Gene Therapy Products
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...
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Sharan Murugan
- Nov 1, 2022
- 1 min
USFDA's Notice: CMC Development & Readiness Pilot Program
Recently in a new program announced by the Food and Drug Administration (USFDA), a limited number of applicants will be able to...
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Sharan Murugan
- Oct 3, 2022
- 1 min
USFDA Guidance: Size, Shape, & Other Physical Attributes of Generic Tablets and Capsules
Earlier today (03-October-2022) USFDA's Center for Drug Evaluation and Research released an important CMC topic and final guidance "...
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Sharan Murugan
- Apr 24, 2022
- 1 min
USFDA Guidance on “Pharm. Quality/CMC Data Exchange" and Drug Products containing Nanoparticles
Draft PQ/CMC Data Exchange for Electronic Submission of PQ/CMC Data On April 22 2022, USFDA, FDA has released the draft document,...
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