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Sharan Murugan
Jun 11, 20211 min read
FDA’s New Draft Guidances on Device Postmarket Surveillance – For Comments
The US Food and Drug Administration (FDA) has issued draft guidance to help Medical Device Manufacturers comply with postmarket...
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Sharan Murugan
May 28, 20211 min read
MDCG offers Guidance on Clinical Investigations – Europe
The European Commission’s Medical Device Coordination Group (MDCG) last week issued guidance providing a set of templates that will be...
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Sharan Murugan
May 28, 20211 min read
FDA Guidance regarding Onsite Inspections during COVID19 (Q&A) - USA
After the publication of the Guidance for "Remote Interactive Evaluations", FDA has updated its "Manufacturing, Supply Chain, and Drug...
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Sharan Murugan
May 28, 20212 min read
Reclassification of certain medical devices -Australia-TGA
The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019(link is external) were made on 12 December 2019, which...
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Sharan Murugan
May 28, 20211 min read
ANDAs for Certain Highly Purified Synthetic Peptide Drug Products
The guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product...
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Sharan Murugan
May 8, 20211 min read
Statement for Extensive Public Access to Clinical Data- ICMRA and WHO
The International Coalition of Medicines Regulatory Authorities (ICMRA) and World Health Organisation (WHO) calls on the pharmaceutical...
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Sharan Murugan
May 8, 20211 min read
Guidance on the Licensing of Biosimilar Products - United Kingdom (MHRA)
What is a Biosimilar Medicine? Biosimilar medicine is a biological medicine that is developed to be highly similar and clinically...
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Sharan Murugan
May 8, 20211 min read
Guidance-Implementation of Decentralised Elements in Clinical Trials–Denmark-Danish Medicines Agency
The purpose of this guidance is to illuminate any challenging areas lacking solutions to sufficiently ensure trial participant's safety...
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