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Sharan Murugan
Jul 5, 20211 min read
Draft guidance for Transdermal Adhesion Systems– US FDA
This guidance provides recommendations for clinical trials designed to assess the adhesion performance of transdermal and topical...
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Sharan Murugan
Jul 5, 20211 min read
Providing Regulatory Submissions in Alternate Electronic Format – US FDA
The US Food and Drug Administration on 1st-July,2021 issued final guidance to assist sponsors in using alternate electronic formats for...
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Sharan Murugan
Jul 1, 20211 min read
Five Drugs as Preferred for COVID-19 Therapeutics - listed by EMA
The European Medicines Agency (EMA) has issued a list of five preferred therapeutics for COVID-19 patients, including four monoclonal...
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Sharan Murugan
Jul 1, 20211 min read
Implementation of ISO standards for the identification of medicinal products (IDMP) in Europe
Introduction – EU Implementation Guide Following the publication of version 2.0 in February 2021, the content of sections 2. Chapters and...
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Sharan Murugan
Jun 30, 20211 min read
Clinical trials: Apply for authorisation in UK – MHRA
This is a recently updated guidance that discusses How to apply for a clinical trial including eligibility, phases, model IMPDs, costs,...
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Sharan Murugan
Jun 27, 20211 min read
Guidance on CMC Changes to an Approved Application- US-FDA
FDA issued final guidance on June 21, 2021 to aid applicants of certain licensed biological products to determine the appropriate...
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Sharan Murugan
Jun 27, 20211 min read
Australian electronic Submission Basics Guide- Australia (TGA)
eCTD and NeeS are the standard electronic submission formats and allow the Common Technical Document (CTD) structure to be provided in an...
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Sharan Murugan
Jun 27, 20211 min read
Guidance on Providing Regulatory Submission in e-Format for Standardized Study Data -US FDA
This guidance and the technical specifications document it incorporates by reference describe the requirements for electronic submission...
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Sharan Murugan
Jun 26, 20211 min read
Draft Guidance on Remanufacturing of Medical Devices- USA-FDA
Medical devices encompass a vast array of products with different technologies, product lifecycles, complexity, intended users, and...
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Sharan Murugan
Jun 26, 20211 min read
Guide to Labels and Leaflets of Human Medicines- IRELAND (HPRA)
Product labels and the package leaflet play an essential part in the safe and effective use of the medicine by both the patients and...
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Sharan Murugan
Jun 26, 20211 min read
Draft Guideline on Computerised Systems & Electronic Data in Clinical Trials -EMA
Computerised systems are being increasingly used in clinical research. The complexity of such systems has evolved rapidly during the last...
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Sharan Murugan
Jun 19, 20211 min read
PIC/S Adapting EU GMP Annex 16 on Authorised Person and Batch Release
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) was established in 1995 as an extension to the Pharmaceutical Inspection...
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Sharan Murugan
Jun 19, 20211 min read
Core Patient-Reported Outcomes in Cancer Clinical Trials - USFDA
This is a DRAFT GUIDANCE distributed for comment purposes only. This guidance provides recommendations to sponsors for the collection of...
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Sharan Murugan
Jun 13, 20211 min read
Open Consultation for EU common standard on electronic product information- EMA
The European Medicines Agency (EMA) on 8th June 2021 launched a stakeholder consultation on a draft EU common standard for electronic...
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Sharan Murugan
Jun 13, 20211 min read
Microsoft to Develop Open-Source Software for the Clinical Research Community
On June 1-2021, Clinical Data Interchange Standards Consortium (CDISC) confirmed that CDISC is teaming up with Microsoft to develop the...
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Sharan Murugan
May 28, 20211 min read
FDA Guidance regarding Onsite Inspections during COVID19 (Q&A) - USA
After the publication of the Guidance for "Remote Interactive Evaluations", FDA has updated its "Manufacturing, Supply Chain, and Drug...
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Sharan Murugan
May 28, 20211 min read
ANDAs for Certain Highly Purified Synthetic Peptide Drug Products
The guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product...
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Sharan Murugan
May 10, 20211 min read
First authorisation under Project Orbis - UK MHRA
Project Orbis is an innovative programme coordinated by the US Food and Drug Administration (FDA) with Canada, Australia, Switzerland,...
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Sharan Murugan
May 8, 20211 min read
Statement for Extensive Public Access to Clinical Data- ICMRA and WHO
The International Coalition of Medicines Regulatory Authorities (ICMRA) and World Health Organisation (WHO) calls on the pharmaceutical...
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Sharan Murugan
May 8, 20211 min read
Expectations & Challenges in Conducting Virtual Inspections- USFDA and EMA
Regulators from 11 agencies, representing the US, the UK, Spain, Germany, and Russia, discussed their views on these challenges and...
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