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USFDA Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products

FDA announced on Monday (29-January-2024) that a draft guidance for the industry is available titled, "Collection of Race and Ethnicity...

Sharan Murugan

Jan 31, 20241 min read

USFDA Guidance: Conducting Remote Regulatory Assessments Questions and Answers

Last Friday (26 January 2024), the FDA Office of Regulatory Affairs announced the availability of a revised draft guidance for the...

Sharan Murugan

Jan 28, 20242 min read

USFDA Guidance: Navigating ANDA Submissions Latest Guidance on ANDA Amendments, Requests, and Labeling Revisions

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released two updated final guidances on 24 January...

Sharan Murugan

Jan 28, 20242 min read

USFDA's ISTAND Pilot Program: Accepts First Submission of AI-Based Digital Tech for Neuroscience

A new submission has been accepted into the FDA's Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program by...

Sharan Murugan

Jan 23, 20242 min read

EMA Guidance: Applying for Orphan Designation, IRIS Guide & Orphan Des Procedural Guidance & Forms

Recently (19 January 2023) the European Medicines Agency released an updated guidance on "IRIS guide for applicants - How to create and...

Sharan Murugan

Jan 22, 20242 min read

WHO Guidance: Ethics and Governance of Artificial Intelligence for Health

The World Health Organization (WHO) released new guidelines (18 January 2023) on ethics and governance of large multi-modal models...

Sharan Murugan

Jan 20, 20241 min read

MHRA Guidance: MAH Submission of Nitrosamine Risk Evaluation, Risk Assessment and Confirmatory Testing

Nitrosamines have become a significant concern in the pharmaceutical industry due to their potential carcinogenicity. In response to this...

Sharan Murugan

Jan 18, 20242 min read

USFDA Guidance: Requests for Reconsideration under GDUFA

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...

Sharan Murugan

Jan 13, 20242 min read

EMA: Guidance on Paediatric Submissions & Scientific Guidelines with SmPC Recommendations

Developing drugs specifically for paediatric use comes with its own set of challenges, including ethical considerations, appropriate...

Sharan Murugan

Jan 13, 20241 min read

UK MHRA: Guidance on 150-Day Assessment for National Applications for Medicines

Earlier today (05 January 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "150-day...

Sharan Murugan

Jan 5, 20242 min read

UK MHRA: Guidance on Operational Information Sharing

Earlier today (02 January 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Operational...

Sharan Murugan

Jan 2, 20241 min read

USFDA : CMC Guidance Reformulating Drug Products That Contain Carbomers & Potency Assurance for Cellular & Gene Therapy Products

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...

Sharan Murugan

Dec 30, 20232 min read

USFDA Guidance: Considerations, Master Protocols for the Development of Drugs and Biological Products

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...

Sharan Murugan

Dec 27, 20232 min read

USFDA Guidance: Digital Health Technologies for Remote Data Acquisition & Data Standards for Drug and Biological Product Submissions and Real-World Data

Earlier this week the the U.S. Food and Drug Administration (FDA) released multiple guidances that is related to Digital Technologies and...

Sharan Murugan

Dec 27, 20232 min read

UK MHRA: Guidance on Submitting Changes to Labelling and Patient Information Leaflets

On 22nd December 2023, the Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance on Medicines "Submitting...

Sharan Murugan

Dec 27, 20232 min read

Singapore's HSA: Post-Industry Consultation Updates on eCTD Implementation in Singapore

On 11th December 2023, Singapore's Health Sciences Authority (HSA) released an update "Post-Industry Consultation Updates on Electronic...

Sharan Murugan

Dec 11, 20231 min read

UK MHRA Guidance: Apply for a Parallel Import Licence

Earlier today (05 December 2023) Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance on Medicines: "Apply for...

Sharan Murugan

Dec 5, 20232 min read

Health Canada: Guidance on Validation rules for Regulatory Transactions in the eCTD Format

Health Canada recently published an updated guidance on "Validation rules for regulatory transactions provided to Health Canada in the...

Sharan Murugan

Nov 30, 20231 min read

USFDA Guidance Q&A: Translation of Good Laboratory Practice Study Reports

On 21 November,2023 the USFDA issued updated guidance on "Translation of Good Laboratory Practice Study Reports: Questions and Answers"...

Sharan Murugan

Nov 24, 20232 min read

UK MHRA: Guidance on Change of Ownership: Marketing Authorisation Process

Last Friday (17 November 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Medicines...

Sharan Murugan

Nov 18, 20232 min read