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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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Orphan designation: Autologous haematopoietic cells genetically modified with a lentiviral vector containing the human gp91(phox) gene Treatment of X-linked chronic granulomatous disease, 09/02/2012 Positive
Source: EMA Published on 2024-11-01
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Guidance on the application of the amended Variations Regulation from 1 January 2025
Source: EMA Published on 2024-10-31
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PSUSA/00010097/202403
Source: EMA Published on 2024-10-31
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 October 2024
Source: EMA Published on 2024-10-31
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PSUSA/00010245/202403
Source: EMA Published on 2024-10-31
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PSUSA/00010809/202403
Source: EMA Published on 2024-10-31
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PSUSA/00010098/202403
Source: EMA Published on 2024-10-31
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PSUSA/00001614/202403
Source: EMA Published on 2024-10-31
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PSUSA/00010002/202403
Source: EMA Published on 2024-10-31
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Parallel distribution: Regulatory and procedural guidance
Source: EMA Published on 2024-10-31
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List of centrally authorised products with safety-related changes to the product information
Source: EMA Published on 2024-10-31
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Orphan designation: Adeno-associated viral vector serotype 1 containing the 3' portion of human OTOF gene, Adeno-associated viral vector serotype 1 containing the 5' portion of human OTOF gene Treatment of otoferlin gene-mediated hearing loss, 20/03/2023 Positive
Source: EMA Published on 2024-10-31
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Orphan designation: Cemdisiran Treatment of primary IgA nephropathy, 20/08/2021 Positive
Source: EMA Published on 2024-10-31
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Orphan designation: Rivoceranib (mesilate) Treatment of hepatocellular carcinoma, 27/09/2024 Positive
Source: EMA Published on 2024-10-31
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Orphan designation: efineptakin alfa Treatment of acute radiation syndrome, 30/09/2024 Positive
Source: EMA Published on 2024-10-31
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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: 30th October 2024
Source: MHRA Published on 2024-10-30
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Class 2 Medicines Recall: Tillomed Laboratories Limited, Labetalol 200mg Tablets, EL(24)A/52
Source: MHRA Published on 2024-10-29
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Field Safety Notices: 21 to 25 October 2024
Source: MHRA Published on 2024-10-29
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Class 4 Medicines Defect Information: Kent Pharma UK, Parasolve (Paracetamol) 500mg effervescent tablets, EL(24)A/51
Source: MHRA Published on 2024-10-28
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Class 2 Medicines Recall: Bristol Laboratories Ltd, Phenobarbital Bristol Labs 15mg Tablets, EL(24)A/50
Source: MHRA Published on 2024-10-23
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Field Safety Notices: 14 to 18 October 2024
Source: MHRA Published on 2024-10-22
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Class 4 Medicines Defect Information: Kent Pharma UK, Paracetamol 500mg Effervescent Tablets, EL(24)A/49
Source: MHRA Published on 2024-10-21
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Field Safety Notices: 18 October 2024
Source: MHRA Published on 2024-10-18
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Field Safety Notices: 7 to 11 October 2024
Source: MHRA Published on 2024-10-16
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Field Safety Notices: 7 October to 14 October 2024
Source: MHRA Published on 2024-10-11
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Class 4 Medicines Defect Information: Sandoz Ltd., Linezolid 600 mg film-coated tablets, EL(24)A/48
Source: MHRA Published on 2024-10-10
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Class 3 Medicines Recall: Viatris UK Healthcare Ltd, Trandolapril 2mg and 4mg capsules, EL(24)A/47
Source: MHRA Published on 2024-10-07
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Field Safety Notices: 30 September to 4 October 2024
Source: MHRA Published on 2024-10-04
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Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Ltd Cyanocobalamin 50 mcg Tablets, EL(24)A/46
Source: MHRA Published on 2024-10-03
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Class 4 Medicines Defect Information: Sandoz Ltd., Rosuvastatin 20mg, 40mg Tablets, EL(24)A/45
Source: MHRA Published on 2024-10-01
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
-
Modernizing the New Drugs Regulatory Program
Source: FDA Published on 2024-06-24
-
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