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Sharan Murugan
Feb 2, 20231 min read
Ireland's HPRA: Guide to Clinical Trial Applications
Recently in January, the Health Products Regulatory Authority (HPRA) of Ireland updated its guidance on "HPRA Guide to Clinical Trial...
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Sharan Murugan
Feb 1, 20231 min read
Health Canada Guidance: Conduct and Analysis of Comparative Bioavailability Studies
Recently (30 January 2023) Health Canada updated their guidance document on "Conduct and Analysis of Comparative Bioavailability...
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Sharan Murugan
Feb 1, 20231 min read
ICH (USFDA) Guidance: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
The USFDA released draft guidance for the industry on January 31, 2023, “M13A Bioequivalence for Immediate-Release Solid Oral Dosage...
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Sharan Murugan
Jan 31, 20231 min read
USFDA Guidance: Design and Conduct of Externally Controlled Trials for Drug and Biological Products
Earlier today, the FDA published a draft guidance for the industry titled, "Considerations for the Design and Conduct of Externally...
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Sharan Murugan
Jan 31, 20231 min read
MHRA Guidance: Innovative Licensing and Access Pathway (updation)
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has updated its guidance information on the Innovative Licensing and...
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Sharan Murugan
Jan 19, 20231 min read
Malaysia MD Guidance: How to Submit an Application for Registration of a Refurbished Medical Device
Malaysia’s Ministrt of Healths Medical Device Authority (MDA) division recently prepared a guideline "Guidelines for implementation of...
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Sharan Murugan
Jan 17, 20231 min read
USFDA Guidance: Content & Format - Dosage and Administration Section of Labeling
Recently on 12-January-2023, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled...
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![USFDA Guidance: Photobiomodulation (PBM) Devices & Premarket Notification [510(k)] Submissions](https://static.wixstatic.com/media/nsplsh_4a67383974757642316951~mv2_d_12000_8000_s_4_2.jpg/v1/fill/w_1596,h_1200,fp_0.50_0.50,q_90,enc_auto/nsplsh_4a67383974757642316951~mv2_d_12000_8000_s_4_2.jpg)
Sharan Murugan
Jan 16, 20231 min read
USFDA Guidance: Photobiomodulation (PBM) Devices & Premarket Notification [510(k)] Submissions
Recently (12-January-2023) the US Food and Drug Administration (FDA) relaeased draft guidance on "Photobiomodulation (PBM) Devices -...
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Sharan Murugan
Jan 16, 20232 min read
EMA Guidance: Format & Validity Features of e-Certificates and How to Fll the Application Form
Yesterday (16-January-2023) European Medicines Agency (EMA) released an udated guideline "Information note on the format and validity...
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Sharan Murugan
Jan 8, 20231 min read
Australia TGA: FAQ Importing & Supplying Medical Devices
Recently on 3rd January, 2023 Australia's Therapeutic Goods Administration (TGA) released a guidance on frequently asked questions...
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Sharan Murugan
Jan 8, 20231 min read
Philippines FDA: Draft Guidance Frontline Services of the FDA in the New Normal
Recently on 4th January, 2023 the Philippines Food and Drug Administration (FDA) released a draft guideline for comments i.e;...
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Sharan Murugan
Jan 8, 20231 min read
Irelands HPRA's: Guide to Fees for Human Products
On 3rd January 2023, Irelands Health Products Regulatory Authority (HPRA) released an updated Guide related to "Fees for Human Products"....
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Sharan Murugan
Jan 4, 20231 min read
USFDA Guidance: Finalized REMS Format, Content and Technical Conformance Guide
The US Food and Drug Administration (FDA) relaeased finalized the guidance on "Format and Content of a REMS Document" and "REMS Document...
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