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Sharan Murugan
- Jun 11, 2021
- 1 min
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The US Food and Drug Administration (FDA) has issued draft guidance to help Medical Device Manufacturers comply with postmarket...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, 2021
- 1 min
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, 2021
- 1 min
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, 2021
- 2 min
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, 2021
- 1 min
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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