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News Archive
FDA - Research on AI/ML-Based Medical Devices
13th June 2024CDRH’s Office of Science and Engineering Laboratories (OSEL) Information.
ICH - Assembly Meeting
13th June 2024ICH Assembly Meeting Write Up, Fukuoka, Japan, June 2024 The Assembly of the International Council for Harmonisation (ICH) met in-person on 4 & 5 June 2024, in Fukuoka, Japan in parallel of meetings of 13 Working Groups, and preceded by meetings of the ICH Management Committee and the MedDRA Management Committee. The ICH continues to expand and welcomed ANMAT, Argentina and JFDA, Jordan as new ICH Members, bringing ICH to a total of 23 Members and 35 Observers.
ICH E6(R3) EWG Work Plan
11th June 2024Published Work Plan
EMA - Annual Report 2023
6th June 2024Published on 30th May 2024 EMA’s annual report 2023 published today details the Agency’s contributions to public and animal health in the European Union (EU). With a fresh layout and new interactive features, the report offers insights into EMA's strategic initiatives and priority areas that guided its work in 2023.
EMA - Human Medicines Highlights Newsletter
6th June 2024May 2024 The newsletter for patients, consumers and healthcare professionals
EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)
6th June 202427-30 May 2024
EMA - Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP)
6th June 202421st - 22nd May 2024
FDA - Platform Technology Designation Program for Drug Development
6th June 2024Guidance Document available for comment
FDA - Processes and Practices Applicable to Bioresearch Monitoring Inspections
6th June 2024The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Processes and Practices Applicable to Bioresearch Monitoring Inspections.”
FDA - Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of BIMO Inspections
6th June 2024Guidance document open for comment.
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