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An insightful session on “ISO: 14155- Introduction to Clinical Investigation for Medical Devices” by Dr. Ashok Thakkar
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We are delighted to welcome Mohit Kapoor as Director – Project Management and Operations Strategy
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Draft qualification opinion for artificial intelligence-based measurement of non-alcoholic steatohepatitis histology in liver biopsies to determine disease activity in NASH/MASH clinical trials
Source: EMA Published on 2024-12-06
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Q&A Clinic on post-authorisation procedure management in IRIS (1), Online, from 11 December 2024, 11:00 (CET) to 11 December 2024, 12:00 (CET)
Source: EMA Published on 2024-12-06
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2024 annual meeting of the members and Coordinating Group of the European network of paediatric research at the EMA (Enpr-EMA), Online, European Medicines Agency, Amsterdam, the Netherlands, 1 October 2024
Source: EMA Published on 2024-12-05
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Ibandronic acid Accord
Source: EMA Published on 2024-12-05
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Human medicines European public assessment report (EPAR): Vantavo (previously Alendronate sodium and colecalciferol, MSD), alendronic acid,colecalciferol, Date of authorisation: 16/10/2009, Revision: 21, Status: Authorised
Source: EMA Published on 2024-12-05
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Clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Scientific guideline
Source: EMA Published on 2024-12-05
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Guidance for applicants seeking scientific support and advice on traditional herbal medicinal products
Source: EMA Published on 2024-12-05
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Human medicines European public assessment report (EPAR): Arsenic trioxide Accord, arsenic trioxide, Date of authorisation: 14/11/2019, Revision: 7, Status: Authorised
Source: EMA Published on 2024-12-05
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Three-year work plan for the Quality Drafting Group (QDG) of the Committee on Herbal Medicinal Products (HMPC)
Source: EMA Published on 2024-12-05
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Data protection notice for the Experts Management Tool and the handling of competing interests
Source: EMA Published on 2024-12-05
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Human medicines European public assessment report (EPAR): Jcovden (previously COVID-19 Vaccine Janssen), COVID-19 vaccine (Ad26.COV2-S [recombinant]), Date of authorisation: 11/03/2021, Revision: 33, Status: Withdrawn (authorisation)
Source: EMA Published on 2024-12-05
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Jcovden : Periodic safety update report assessment 25 February 2023 to 24 February 2024
Source: EMA Published on 2024-12-05
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Human medicines European public assessment report (EPAR): Duloxetine Viatris (previously Duloxetine Mylan), duloxetine, Date of authorisation: 19/06/2015, Revision: 20, Status: Authorised
Source: EMA Published on 2024-12-04
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How to pay
Source: EMA Published on 2024-12-04
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How to pay fees and charges levied by EMA: Guidance to marketing authorisation holders and applicants
Source: EMA Published on 2024-12-04
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Know Which Medication Is Right for Your Seasonal Allergies
Source: FDA Published on 2024-06-25
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Sani-Care Salon Products, Inc. - 673747 - 04/24/2024
Source: FDA Published on 2024-06-25
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Glenmark Pharmaceuticals Inc., USA Issues Voluntary Nationwide Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due to Failed Dissolution
Source: FDA Published on 2024-06-25
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Report | Drug Shortages: Root Causes and Potential Solutions
Source: FDA Published on 2024-06-24
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FDA approves treatment for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults
Source: FDA Published on 2024-06-24
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Facilitating Generic Drug Product Development through Product-Specific Guidances - 04/25/2024
Source: FDA Published on 2024-06-24
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Modernizing the New Drugs Regulatory Program
Source: FDA Published on 2024-06-24
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FDA grants accelerated approval to adagrasib with cetuximab for KRAS G12C-mutated colorectal cancer
Source: FDA Published on 2024-06-21
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Public Workshop: Best Practices for Meeting Management Under PDUFA VII - 07/22/2024
Source: FDA Published on 2024-06-21
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Center for Drug Evaluation and Research National Survey on Numerical Claims in Prescription Drug Advertising
Source: FDA Published on 2024-06-20
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Infla-650 contains hidden drug ingredients
Source: FDA Published on 2024-06-20
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Cefdinir - Oral products
Source: FDA Published on 2024-06-20
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Considerations in Demonstrating Interchangeability With a Reference Product: Update
Source: FDA Published on 2024-06-20
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Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
Source: FDA Published on 2024-06-20
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FDA updates guidance on interchangeability
Source: FDA Published on 2024-06-20
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Field Safety Notices: 25 to 29 November 2024
Source: MHRA Published on 2024-12-05
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Class 4 Medicines Defect Information: Brillpharma Limited, Oxybutynin hydrochloride Brillpharma 2.5 mg/5 ml Oral Solution, EL(24)A/61
Source: MHRA Published on 2024-12-04
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Class 4 Medicines Defect Information: Kent Pharma UK, Phenoxymethylpenicillin 250mg/5ml Oral Solution Sugar Free, EL (24)A/60
Source: MHRA Published on 2024-12-03
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Class 4 Medicines Defect Information: Rosemont Pharmaceuticals Limited, Mycophenolate Mofetil 1g/5ml Oral Suspension, EL(24)A/59
Source: MHRA Published on 2024-12-02
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Class 4 Medicines Defect Information: Strides Pharma UK Ltd, Liothyronine Sodium 5 & 20 micrograms Tablets, EL(24)A/58
Source: MHRA Published on 2024-11-28
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Class 4 Medicines Defect Information: Morningside Healthcare Limited, Tramadol Hydrochloride 50 mg capsules & Tramadol Hydrochloride Morningside 50 mg Prolonged-Release capsules, EL(24)A/57
Source: MHRA Published on 2024-11-27
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Field Safety Notices: 18 to 22 November 2024
Source: MHRA Published on 2024-11-26
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Field Safety Notices: 25 November 2024
Source: MHRA Published on 2024-11-26
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Class 3 Medicines Recall: Syri Limited, T/A SyriMed, Baclofen 10mg/5ml Oral Solution, EL(24)A/56
Source: MHRA Published on 2024-11-25
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Field Safety Notices: 11 to 15 November 2024
Source: MHRA Published on 2024-11-19
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Class 4 Medicines Defect Information: Takeda UK Limited, Entyvio 108mg solution for injection in pre-filled syringe, EL(24)A/55
Source: MHRA Published on 2024-11-18
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Company led medicines recall: Leeds Trading Company LTC Ltd T/A LTC Healthcare, EXS Delay Spray Plus, CLMR(24)A/01
Source: MHRA Published on 2024-11-13
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Class 4 Medicines Defect Information: Viatris UK Healthcare Ltd, Omeprazole 40 mg Powder for solution for infusion, EL(24)A/54
Source: MHRA Published on 2024-11-12
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Field Safety Notices: 4 to 8 November 2024
Source: MHRA Published on 2024-11-12
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Field Safety Notices: 8 November 2024
Source: MHRA Published on 2024-11-08
FDA
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Know Which Medication Is Right for Your Seasonal Allergies
Source: FDA Published on 2024-06-25
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Sani-Care Salon Products, Inc. - 673747 - 04/24/2024
Source: FDA Published on 2024-06-25
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Glenmark Pharmaceuticals Inc., USA Issues Voluntary Nationwide Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due to Failed Dissolution
Source: FDA Published on 2024-06-25
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Report | Drug Shortages: Root Causes and Potential Solutions
Source: FDA Published on 2024-06-24
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FDA approves treatment for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults
Source: FDA Published on 2024-06-24
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Facilitating Generic Drug Product Development through Product-Specific Guidances - 04/25/2024
Source: FDA Published on 2024-06-24
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Modernizing the New Drugs Regulatory Program
Source: FDA Published on 2024-06-24
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FDA grants accelerated approval to adagrasib with cetuximab for KRAS G12C-mutated colorectal cancer
Source: FDA Published on 2024-06-21
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Public Workshop: Best Practices for Meeting Management Under PDUFA VII - 07/22/2024
Source: FDA Published on 2024-06-21
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Center for Drug Evaluation and Research National Survey on Numerical Claims in Prescription Drug Advertising
Source: FDA Published on 2024-06-20
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Infla-650 contains hidden drug ingredients
Source: FDA Published on 2024-06-20
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Cefdinir - Oral products
Source: FDA Published on 2024-06-20
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Considerations in Demonstrating Interchangeability With a Reference Product: Update
Source: FDA Published on 2024-06-20
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Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
Source: FDA Published on 2024-06-20
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FDA updates guidance on interchangeability
Source: FDA Published on 2024-06-20