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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FDA announced on Monday (29-January-2024) that a draft guidance for the industry is available titled, "Collection of Race and Ethnicity...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: Human Gene Therapy Products Incorporating Human Genome Editing & Development of Chimeric Antigen Receptor (CAR) T Cell Products
On Monday (29 January 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation released two...
Sharan Murugan
Jan 31, 20242 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Last Friday (26 January 2024), the FDA Office of Regulatory Affairs announced the availability of a revised draft guidance for the...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'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
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
USFDA Guidance: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions
Yesterday (08 January, 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices...
Sharan Murugan
Jan 9, 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
Malaysia NPRA: Guidelines for Registration of Biosimilars in Malaysia
Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (13 December 2023) released an updated guidance on "Guidelines for...
Sharan Murugan
Dec 19, 20231 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
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
Swiss Medic: Biosimilar Authorisation Guidance
Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance on (26 November 2023) the "Guidance document...
Sharan Murugan
Nov 26, 20232 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