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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...

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...

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...

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...

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...

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...

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...

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...

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...