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UK MHRA: Guidance on International Recognition Procedure
Recently the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released a guidance on "International Recognition Procedure"...
Sharan Murugan
Sep 10, 20231 min read
90 views
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Australia's TGA: Reclassification of Medical Devices & Variations to Prescription Medicines
Yesterday (21-August-2023) Australia's Therapeutic Goods Administration (TGA) released multiple guidances on the "Reclassification of...
Sharan Murugan
Aug 22, 20232 min read
45 views
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USFDA Guidance: Informed Consent Guidance for IRBs, Clinical Investigators, & Sponsors
The U.S. Food and Drug Administration (FDA) released its final guidance this Tuesday (15 August 2023), "Informed Consent: Guidelines for...
Sharan Murugan
Aug 17, 20231 min read
39 views
0 comments
USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products
Today (11 August 2023) the United States Food & Drug Administration released a draft guidance “Formal Meetings Between the FDA and...
Sharan Murugan
Aug 10, 20232 min read
42 views
0 comments
USFDA Guidance: QTc Information in Prescription Drug & Biological Product Labeling
Recently on 08 August 2023, the United States Food & Drug Administration's Oncology Center of Excellence, Center for Drug Evaluation and...
Sharan Murugan
Aug 10, 20232 min read
37 views
0 comments
USFDA Guidance: Recommended Acceptable Intake Limits for Nitrosamine DS-Related Impurities
Today (04 August 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research and Center for Drug...
Sharan Murugan
Aug 4, 20232 min read
134 views
0 comments
USFDA Guidance: Waivers, Exceptions, & Exemptions from Section 582 of FD&C Act
Today (04 August 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research and Center for Drug...
Sharan Murugan
Aug 4, 20232 min read
40 views
0 comments
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...
Sharan Murugan
Aug 1, 20232 min read
16 views
0 comments
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"...
Sharan Murugan
Jul 30, 20232 min read
363 views
0 comments
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...
Sharan Murugan
Jul 30, 20231 min read
32 views
0 comments
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 &...
Sharan Murugan
Jul 30, 20232 min read
6 views
0 comments
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...
Sharan Murugan
Jul 30, 20231 min read
94 views
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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...
Sharan Murugan
Jul 30, 20232 min read
215 views
0 comments
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...
Sharan Murugan
Jul 24, 20232 min read
30 views
0 comments
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...
Sharan Murugan
Jul 24, 20232 min read
14 views
0 comments
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"...
Sharan Murugan
Jul 21, 20232 min read
50 views
0 comments
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...
Sharan Murugan
Jul 17, 20232 min read
49 views
0 comments
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...
Sharan Murugan
Jul 17, 20231 min read
26 views
0 comments
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...
Sharan Murugan
Jul 15, 20232 min read
36 views
0 comments
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...
Sharan Murugan
Jul 15, 20232 min read
29 views
0 comments