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Sharan Murugan
Oct 1, 20232 min read
EC Q&A Guidance: Questions & Answers: Clinical Trials Regulation
Recently this Friday (29-Sepetember, 2023), the European Commission's Clinical Trials Coordination and Advisory Group released an updated...
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Sharan Murugan
Oct 1, 20231 min read
EMA Guidance: Pre-Authorisation Procedural Advice for Users of the Centralised Procedure
Last Friday (29 September 2023) the European Medicines Agency released an updated guidance on "European Medicines Agency...
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Sharan Murugan
Oct 1, 20231 min read
MHRA Guidance: The Northern Ireland MHRA Authorised Route (NIMAR)
On 29 September 2023 UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "The Northern Ireland...
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Sharan Murugan
Sep 21, 20232 min read
USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants -PDUFA Products
The FDA Center for Drug Evaluation and Research, along with the FDA Center for Biologics Evaluation and Research, issued a revised draft...
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Sharan Murugan
Sep 21, 20231 min read
USFDA Guidance: Conduct of Clinical Trials of Medical Products During Major Disruptions
Today (21 September 2023) CDER, along with the FDA Center for Biologics Evaluation and Research, Center for Devices and Radiological...
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Sharan Murugan
Sep 20, 20232 min read
USFDA Guidance: Regulatory Considerations for Prescription Drug Use-Related Software
Yesterday (19 September 2023) the U.S. Food and Drug Administration (FDA) released two draft guidance "Regulatory Considerations for...
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Sharan Murugan
Sep 20, 20232 min read
USFDA Guidance: Labeling for Biosimilar & Interchangeable Biosimilar Products
Earlier this Monday (18 September 2023), The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center...
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Sharan Murugan
Sep 11, 20231 min read
TGA Guidance: Submitting data in the eCTD format
Recently (7th Spetember, 2023) Australia's Therapeutic Goods Administration (TGA) released revised and updated guidance "Submitting data...
119 views0 comments
Sharan Murugan
Sep 11, 20232 min read
USFDA Guidance: IRB Review of Individual Patient Expanded Access Submissions & Peptide Drug Products
Earlier today (11 September 2023), The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, Center for...
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Sharan Murugan
Sep 10, 20232 min read
USFDA Guidance: Post-Warning Letter Meetings & Interoperable Exchange of Information
Recently on 05 September 2023, the United States Food & Drug Administration's Center for Drug Evaluation and , Research, Center for...
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Sharan Murugan
Sep 9, 20231 min read
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"...
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Sharan Murugan
Aug 22, 20232 min read
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...
36 views0 comments
Sharan Murugan
Aug 17, 20231 min read
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...
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Sharan Murugan
Aug 10, 20232 min read
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...
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Sharan Murugan
Aug 10, 20232 min read
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...
23 views0 comments
Sharan Murugan
Aug 4, 20232 min read
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...
115 views0 comments
Sharan Murugan
Aug 4, 20232 min read
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...
33 views0 comments
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...
14 views0 comments
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"...
195 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...
26 views0 comments