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Sharan Murugan
- Mar 13
- 1 min
USFDA Med.Dev: Draft Guidance Select Updates for the Premarket Cybersecurity -Section 524B of the FD&C Act
Today (13 March, 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices and...
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Sharan Murugan
- Mar 13
- 1 min
ICH (Final) Guidance: Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development
Last week the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, Office of Regulatory Policy, and the...
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Sharan Murugan
- Mar 13
- 1 min
UK MHRA: Guidance on Established Medicines Marketing Authorisation Application Process Changes
The UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance "Established Medicines Marketing Authorisation...
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Sharan Murugan
- Mar 7
- 2 min
UK MHRA: Guidance on Packaging, Labelling and Patient Information Leaflets
Earlier today (08 March 2024) Medicines and Healthcare Products Regulatory Agency (MHRA) updated its "Guidance on Medicines: Packaging,...
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Sharan Murugan
- Mar 5
- 2 min
India CDSCO: Draft Guidance on Post Approval Changes (PAC’s) for Biologicals for consulataion
India's Central Drugs Standard Control Organization (CDSCO) has published draft guidance "Post Approval Changes in Biological Products:...
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