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Sharan Murugan
Sep 14, 20222 min read
USFDA: Office of New Drugs Research Program & Guidance - Software Assurance for Production & Quality
Yesterday (13-September,2022) FDA published a new webpage to share the most recent research activities of the Center for Drug Evaluation...
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Sharan Murugan
Sep 8, 20221 min read
USFDA Guidance: Submitting Documents Using Real-World Data & RW Evidence for Drug & Biologics
Earlier today (08-September-2022) USFDA's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research...
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Sharan Murugan
Sep 8, 20222 min read
USFDA Guidance: Content & Format of Labeling for Non-Prescription Drugs, Quantitative Labeling
Earlier today on 8-September-2022, USFDA's Center for Drug Evaluation and Research, Office of New Drugs published two draft Labeling...
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Sharan Murugan
Sep 8, 20221 min read
USFDA Guidance: Clinical Pharmacology Considerations for Pediatric Studies of Drugs & Biologics
Yesterday 07-September-2022, USFDA's Center for Drug Evaluation and Research published a draft guideline "General Clinical Pharmacology...
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Sharan Murugan
Sep 7, 20221 min read
UK MHRA's Guidance: Software Applications (apps)
Recently the MHRA updated its Medical devices: Software Applications (apps) guidance, which provides information on when software...
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Sharan Murugan
Sep 7, 20221 min read
Malaysia’s MDA: HARMONISED CLASSIFICATION OFMEDICAL DEVICES IN ASEAN
Association of Southeast Asian Nations, or ASEAN, is a political and economic union of 10 members states in Southeast Asia, which are...
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Sharan Murugan
Sep 4, 20221 min read
SwissMedic Guidance: On Export Certificates
On 1-September, 2022 Swissmedic released the updated guidance on " Guidance document On Export Certificates". Swissmedic issues export...
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Sharan Murugan
Sep 4, 20221 min read
IRIS Updated Guide: How to Create & Submit Scientific Applications & Accelerating Clin. Trials Plan
On 2-September, 2022 the European Medicines Agency released the updated IRIS guidance on "How to create and submit scientific...
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Sharan Murugan
Sep 2, 20221 min read
Colombia INVIMA: Guidelines on the Application related to Sanitary Registries of Medical Devices
The National Institute for Food and Drug Surveillance - Invima, informs manufacturers and importers of controlled technology medical...
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