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Sharan Murugan
Aug 1, 20232 min read
USFDA Guidance: Assessing User Fees -BsUFA III: Biosimilar User Fee Amendments of 2022
Today (31 July 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research and Center for Drug...
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Sharan Murugan
Jul 30, 20232 min read
Malaysia NPRA: Guidance on Drug Registration
Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (26 July, 2023) released an updated guidance on "Drug Registration"...
218 views0 comments
Sharan Murugan
Jul 30, 20231 min read
Canada HC Guidance: Nitrosamine Impurities in Medications
Last Friday (28 July, 2023) Health Canada published an updated "Guidance on Nitrosamine Impurities in Medications" that details about...
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Sharan Murugan
Jul 30, 20232 min read
USFDA Med Dev Guidance: On Opioid Use Disorder & Hydrogen Peroxide-Based Contact Lens Care Products
Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder Last week (26 June, 2023) the United States Food &...
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Sharan Murugan
Jul 30, 20231 min read
UK MHRA: Guidance on Renewing Marketing Authorisations & Implementation of Med Dev. Future Regime
Guidance on Renewing Marketing Authorisations Recently (28, July 2023) the UK's Medicines and Healthcare Products Regulatory Agency...
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Sharan Murugan
Jul 30, 20232 min read
UK MHRA: Guidance on Labelling & Packaging of Medicinal Products - Windsor Framework
On 27 July 2023 UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Labelling and packaging of...
194 views0 comments
Sharan Murugan
Jul 24, 20232 min read
USFDA Guidance: ICH M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities
Earlier today (25 June, 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research, and Center for...
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Sharan Murugan
Jul 24, 20232 min read
EC Guidance: Transition from Clinical Trials Directive to the Clinical Trials Regulation
The European Commission (EC) has long recognized the importance of streamlining and harmonizing the regulation of clinical trials across...
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Sharan Murugan
Jul 21, 20232 min read
Switzerland's SwissMedic: Harmonisation of the SwissGMP/GDP Inspection System
Yesterday (20 July 2023) Switzerland's Swissmedic released an updated guidance on "Harmonisation of the SwissGMP/GDP Inspection System"...
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Sharan Murugan
Jul 17, 20232 min read
USFDA Guidance: Qualification of Medical Device Development Tools
Today (17 July 2023) the USFDA's Center for Devices and Radiological Health (CDRH) released final guidance on "Qualification of Medical...
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Sharan Murugan
Jul 17, 20231 min read
MHRA Med Dev Guidance: In-Vitro Diagnostic Medical Devices on Legislation
Earlier today (17 July, 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "The...
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Sharan Murugan
Jul 15, 20232 min read
Ireland HPRA: Guidance on Parallel Imports of Human Medicines
Irelands Health Products Regulatory Authority (HPRA) released guidance on "Guide to Parallel Imports of Human Medicines" last week (12...
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Sharan Murugan
Jul 15, 20232 min read
USFDA Guidance: Manufacturing Changes & Comparability for CGT Products, Good Cause for Noncompliance
Last Week (13th & 14th July 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research, and Center for...
29 views0 comments
Sharan Murugan
Jul 15, 20231 min read
EMA Guidance: Compilation of Union Procedures on Inspections & Exchange of Information
Yesterday (14 July 2023) the European Medicines Agency released an updated regulatory and procedural guideline "Compilation of Union...
340 views0 comments
Sharan Murugan
Jul 12, 20231 min read
USFDA Guidance: Considerations for Optimizing & Standardizing Diet in Clinical Trials (IEM)
Yesterday (11 July, 2023) the USFDA's Center for Drug Evaluation and Research (CDER) released updated guidance on "Inborn Errors of...
36 views0 comments
Sharan Murugan
Jul 12, 20231 min read
Malaysia’s NPRA: Guideline on Manufacturer’s, Import, Wholesaler’s Licenses & Nitrosamine Impurity
Today (12 July, 2023) the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia published a guideline on "Application of...
119 views0 comments
Sharan Murugan
Jul 4, 20231 min read
Pakistan's DRAP: Guidelines for Post-Registration Variation of Drugs
Earlier today (04 July, 2023), the Drug Regulatory Authority of Pakistan released an updated draft guidance on "Guidelines for...
144 views0 comments
Sharan Murugan
Jul 4, 20232 min read
EMA Guideline: Notification of Serious Breaches or the Cinical Trial Protocol
Today (04 July 2023) the European Medicines Agency released a scientific guideline "Guideline for the notification of serious breaches of...
601 views0 comments
Sharan Murugan
Jul 3, 20231 min read
EMA Guidance: Parallel EMA/HTA body (HTAb) Scientific Advice for the Interim Period
Earlier today (03 July 2023) the European Medicines Agency released updated guidance on "Guidance on Parallel EMA/HTA body (HTAb)...
67 views0 comments
Sharan Murugan
Jul 2, 20231 min read
UK MHRA MD Guidance: Borderlines with Medical Devices & Other Products in Great Britain
Yesterday(01 July 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidelines on the "Borderlines...
32 views0 comments