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  • Our Expertise
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Blog
The Evolution of PRO Collection: From Paper Diaries to ePRO Systems
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Transforming Complexity into Success: A Large-Scale Global Phase III Biosimilar Dermatology Trial
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Biometrics
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Clinical Services
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CT Quality Assurance
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Medical Affairs
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Pulmonary Disease Introduction: Prevalence, Causes, Prevention & Treatment
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Strategic Planning for Patient Recruitment
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  • EMA
  • FDA
  • MHRA
  • Summary of the Medicine Shortages SPOC Working Party meeting on 17 June 2025
    Source: EMA Published on 2025-07-29
  • Nitrosamine impurities
    Source: EMA Published on 2025-07-29
  • Report: European medicines regulatory network’s response to nitrosamine impurities in human medicines
    Source: EMA Published on 2025-07-29
  • Human medicines European public assessment report (EPAR): Osvyrti, denosumab, Date of authorisation: 26/05/2025, Status: Authorised
    Source: EMA Published on 2025-07-28
  • Human medicines European public assessment report (EPAR): Hukyndra, adalimumab, Date of authorisation: 15/11/2021, Revision: 10, Status: Authorised
    Source: EMA Published on 2025-07-28
  • Human medicines European public assessment report (EPAR): Jubereq, denosumab, Date of authorisation: 26/05/2025, Status: Authorised
    Source: EMA Published on 2025-07-28
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  • FDA approves pembrolizumab for adenocarcinoma
    Source: FDA Published on 2025-04-08
  • Approved Drug Products with Therapeutic Equivalence Evaluations (Orang
    Source: FDA Published on 2025-04-08
  • Additions/Deletions for Prescription and OTC Drug Product Lists
    Source: FDA Published on 2025-04-08
  • Recalls small number of acne products for benzene contamination
    Source: FDA Published on 2025-04-08
  • FDA Drug Shortages
    Source: FDA Published on 2025-04-08
  • FDA Drug Shortages
    Source: FDA Published on 2025-04-08
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  • Updated guidance on the management of the recalled Endologix Nellix EndoVascular Aneurysm Sealing (EVAS) System (DSI/2025/004)
    Source: MHRA Published on 2025-07-28
  • Class 2 Medicines Recall: ChloraPrep 1mL Clear Sterile Solution/Applicator, Becton Dickinson UK Ltd, EL(25)A/36
    Source: MHRA Published on 2025-07-28
  • Class 2 Medicines Recall: Flutiform 250 micrograms / 10 micrograms per actuation pressurised inhalation, suspension , CD Pharma Ltd, EL(25)A/35
    Source: MHRA Published on 2025-07-24
  • Trinity Biotech Premier Hb9210™ HbA1c Analyser: Risk of Positive Bias and Updates to Instructions for Use (IFU), including use as a diagnostic aid in diabetes mellitus (DSI/2025/003)
    Source: MHRA Published on 2025-07-22
  • Field Safety Notices: 14 to 18 July 2025
    Source: MHRA Published on 2025-07-22
  • Field Safety Notices: 7 to 11 July 2025
    Source: MHRA Published on 2025-07-21
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