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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 9, 20231 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...

Sharan Murugan

Aug 22, 20232 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...

Sharan Murugan

Aug 17, 20231 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Today (11 August 2023) the United States Food & Drug Administration released a draft guidance “Formal Meetings Between the FDA and...

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...

Sharan Murugan

Aug 10, 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...

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...

Sharan Murugan

Aug 4, 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...

Sharan Murugan

Aug 1, 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"...

Sharan Murugan

Jul 30, 20232 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...

Sharan Murugan

Jul 30, 20231 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 &...

Sharan Murugan

Jul 30, 20232 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...

Sharan Murugan

Jul 30, 20231 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...

Sharan Murugan

Jul 30, 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...

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...

Sharan Murugan

Jul 24, 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"...

Sharan Murugan

Jul 21, 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...

Sharan Murugan

Jul 17, 20232 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...

Sharan Murugan

Jul 17, 20231 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...

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...

Sharan Murugan

Jul 15, 20232 min read