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Sharan Murugan
Jun 52 min read
EMA Guidance: IRIS Guide for Applicants
On 03-June-2024 the European Medicines Agency released an updated "IRIS Guide for Applicants" that guides How to create, submit and...
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Sharan Murugan
Nov 27, 20221 min read
Irelands HPRA's: Medical Device Guide to Clinical Investigations Carried Out in Ireland
On 18th November, 2022 Irelands Health Products Regulatory Authority (HPRA) released an updated Guide related to "Clinical Investigations...
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Sharan Murugan
Nov 16, 20221 min read
Irelands HPRA MD Guide: Performance Studies Conducted in Ireland
Irelands Health Products Regulatory Authority (HPRA) released (16- November-2022) guide on "Performance Studies Conducted in Ireland", to...
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Sharan Murugan
Nov 12, 20221 min read
USFDA POLICY AND PROCEDURES: Quality Assessment for Products in Expedited Programs
Recently (10 November 2022), the U.S. Food and Drug Administration published a new Manual of Policies and Procedures (MAPP), MAPP 5015.13...
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Sharan Murugan
Jun 7, 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...
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Sharan Murugan
May 26, 20221 min read
USFDA- Q&A Guide on Importation of Prescription Drugs from Canada
Yesterday, FDA issued a Small Entity Compliance Guide to help small businesses comply with the final rule on importation of prescription...
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Sharan Murugan
Mar 30, 20221 min read
Guide to Wholesaling & Brokering of Medicinal Products - Ireland
The Health Products Regulatory Authority (HPRA) Ireland released updated guidance on the "Guide to Wholesaling and Brokering of...
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Sharan Murugan
Mar 30, 20221 min read
Guide on Microplastic Usage - IPEC Europe and IPEC-Americas "How to Document"
A new how-to guide was published by the International Pharmaceutical Excipients Council (IPEC) to assist the pharmaceutical industry in...
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