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USFDA Guidance: Multiple Endpoints in Clinical Trials & Gene Therapy for Neurodegenerative Diseases
Earlier on 21 October 2022, the USFDA released two finalized guidances "Multiple Endpoints in Clinical Trials" and "Human Gene Therapy...
Sharan Murugan
Oct 23, 20221 min read
EMA- New Guidance on Complex Clinical Trials
On 2 June, an official Q&A prepared by the European Commission (EC), European Medicines Agency (EMA), and the Heads of Medicines Agencies...
Sharan Murugan
Jun 7, 20221 min read
Guidance for Clinical Trials Conducted under the Clinical Trials Regulation (CTR) in Ireland
On 3-February, 2022 Ireland adopted a new guideline the "EU Clinical Trial Regulation" (Regulation No 536/2014, hereafter ‘CTR’), was...
Sharan Murugan
Feb 6, 20221 min read
UK Guidance on Clinical Trials: How to Apply for Authorization
UK MHRA updated its guidance on How to apply for a clinical trial including eligibility, phases, model IMPDs, costs, and how to make...
Sharan Murugan
Jan 16, 20221 min read
Finland adopts New Act on Clinical Trials Legislation (FIMEA)
The Parliament of Finland has adopted a new Act on Clinical Trials on 8 October 2021. The Parliament also approved amendments to the...
Sharan Murugan
Nov 7, 20211 min read
Clinical Trials Information System (CTIS) to go-live in 6 Months – EMA
The European Commission has confirmed that the entry into application of the Clinical Trials Regulation and hence the go-live date for...
Sharan Murugan
Aug 3, 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,...
Sharan Murugan
Jun 30, 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This is a DRAFT GUIDANCE distributed for comment purposes only.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...
Sharan Murugan
Jun 19, 20211 min read