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News Archive
FDA - Roundup, 30th August 2024
5th September 2024An at-a-glance summary of news from around the agency
FDA - Warning Letter to Italian Company
5th September 2024The warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. 3. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).
MHRA - Advertising Investigations
5th September 2024Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.
MHRA - Appointments of four MHRA Non-Executive Directors extended until 31 August 2025
5th September 2024Extended from 1 September 2024 until 31 August 2025.
MHRA - Consultation on Statutory Fees
5th September 2024Proposals on ongoing cost recovery
MHRA - Pharmacovigilance following agreement of the Windsor Framework
5th September 2024MHRA have published information on the implementation of changes to pharmacovigilance for medicines authorised in the UK following the agreement of the Windsor Framework.
WHO - Guidance aims to curb antibiotic pollution from manufacturing
5th September 2024New global guidance released
MHRA - Performance Metrics Published
16th August 2024MHRA performance metrics for clinical trials and established medicines assessment.
EMA - Veterinary Scientific Guidance Update - Adopted and Draft Guidance
14th August 2024New adopted and draft guidelines relating to Veterinary Products
MHRA - Medicines Pipeline data
14th August 2024New Guidance Published
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