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Sharan Murugan
Mar 3, 20221 min read
USFDA Guidance: Methods to Identify What Is Important to Patients
On 28-February-2022, the US Food and Drug Administration (FDA) finalized guidance to assist sponsors in collecting and submitting...
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Sharan Murugan
Mar 3, 20221 min read
EU Guidelines for Good Manufacturing Practice for Medicinal Products
As part of the manufacturing import authorisation (MIA) process, the Annex outlines the GMP requirements that must be followed when...
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Sharan Murugan
Mar 3, 20221 min read
EU Common Standard for electronic Pproduct Information
ePI refers to medicines' authorised, statutory information (including summary of product characteristics, package leaflet and labeling)...
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Sharan Murugan
Feb 24, 20221 min read
Guidance on Innovative Medical Devices - Saudi Food and Drug Authority
Medical devices that are innovative play an important role in improving and facilitating the quality of life of both patients and...
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Sharan Murugan
Feb 20, 20221 min read
Irelands HPRA Guide to Classification of a Medical Device
Throughout this guide, guidance is given on the qualification of medical devices and the application of classification rules. There is a...
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Sharan Murugan
Feb 20, 20221 min read
Ireland’s HPRA - Guidance update on Submitting Mock-ups for Labels and Leaflets
A number of important revisions and clarifications were made in the HPRA's Guide to Labels and Leaflets of Human Medicines on 9 February...
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Sharan Murugan
Feb 13, 20221 min read
Malaysia's Medical Device Authority Guidance on Refurbished Medical Devices.
Malaysia's Medical Device Authority (MDA) has published guidelines to help manufacturers and authorized representatives submit...
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Sharan Murugan
Feb 13, 20221 min read
US FDA CDER Guidance Agenda -Calendar Year 2022
In 2022, CDER will publish new and revised guidances in its Guidance Agenda, which was released on January 31, 2022. The 2022 list...
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Sharan Murugan
Feb 6, 20221 min read
USFDA - Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs
US Food and Drug Administration (FDA) issued draft guidance discussing formal meetings between sponsors of over-the-counter (OTC)...
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Sharan Murugan
Feb 6, 20221 min read
Guidance for Clinical Trials Conducted under the Clinical Trials Regulation (CTR) in Ireland
On 3-February, 2022 Ireland adopted a new guideline the "EU Clinical Trial Regulation" (Regulation No 536/2014, hereafter ‘CTR’), was...
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Sharan Murugan
Feb 6, 20221 min read
Revision of PIC/S GMP Guide
On 1-February 2022, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) this week revised its good manufacturing practice (GMP)...
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