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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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EMEA-003429-PIP01-23
Source: EMA Published on 2024-09-13
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EMEA-003429-PIP02-23
Source: EMA Published on 2024-09-13
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EMEA-003431-PIP01-23
Source: EMA Published on 2024-09-13
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EMEA-002773-PIP01-20-M01
Source: EMA Published on 2024-09-13
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EMEA-002699-PIP01-19-M01
Source: EMA Published on 2024-09-13
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EMEA-002677-PIP01-19-M03
Source: EMA Published on 2024-09-13
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EMEA-002653-PIP01-19-M01
Source: EMA Published on 2024-09-13
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EMEA-002635-PIP02-21-M02
Source: EMA Published on 2024-09-13
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Opinion/decision on a Paediatric investigation plan (PIP): Verzenios, abemaciclib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0313/2023
Source: EMA Published on 2024-09-13
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Opinion/decision on a Paediatric investigation plan (PIP): Verzenios, abemaciclib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0312/2023
Source: EMA Published on 2024-09-13
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Opinion/decision on a Paediatric investigation plan (PIP): Lynparza, Olaparib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0320/2023
Source: EMA Published on 2024-09-13
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Opinion/decision on a Paediatric investigation plan (PIP): Leqvio, Inclisiran sodium, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism, PIP number: P/0322/2023
Source: EMA Published on 2024-09-13
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Opinion/decision on a Paediatric investigation plan (PIP): Imjudo, Tremelimumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0302/2023
Source: EMA Published on 2024-09-13
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Opinion/decision on a Paediatric investigation plan (PIP): Imfinzi, durvalumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0301/2023
Source: EMA Published on 2024-09-13
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Opinion/decision on a Paediatric investigation plan (PIP): Namuscla, Mexiletine hydrochloride, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: P/0300/2023
Source: EMA Published on 2024-09-13
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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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Class 3 Medicines Recall: Theramex HQ UK Ltd, Evorel Sequi, EL (24)A/41
Source: MHRA Published on 2024-09-12
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Field Safety Notices: 2 to 6 September 2024
Source: MHRA Published on 2024-09-06
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Field Safety Notices: 26 to 30 August 2024
Source: MHRA Published on 2024-09-04
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CPT Hip System Femoral Stem 12/14 Neck Taper: Increased Risk of Postoperative Periprosthetic Femoral Fracture, DSI/2024/007
Source: MHRA Published on 2024-09-04
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Philips Respironics BiPAP A series ventilators: alarm malfunction and risk of therapy interruptions in ventilators not intended for life-support, DSI/2024/006
Source: MHRA Published on 2024-08-28
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Class 4 Medicines Defect Information: Chemidex Pharma Ltd, Ponstan 250mg Capsules & 500mg Tablets (mefenamic acid), EL(24)A/40
Source: MHRA Published on 2024-08-27
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Field Safety Notices: 19 to 23 August 2024
Source: MHRA Published on 2024-08-27
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Field Safety Notices: 12 to 16 August 2024
Source: MHRA Published on 2024-08-19
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Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Ltd, Fingolimod 0.5 mg Hard Capsules, EL(24)A/39
Source: MHRA Published on 2024-08-19
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Field Safety Notices: 5 to 9 August 2024
Source: MHRA Published on 2024-08-16
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Class 2 Medicines Recall: Strides Pharma UK Limited, Loperamide Hydrochloride Capsules 2mg, EL(24)A/38
Source: MHRA Published on 2024-08-15
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Class 4 Medicines Defect Information: Dawa Limited, Trazodone Hydrochloride 50mg, 100mg Capsules & 50mg/5ml Oral Solution, EL (24)A/37
Source: MHRA Published on 2024-08-14
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Class 4 Medicines Notification, Star Pharmaceuticals Limited, Diflucan Oral Suspension 40mg/ml, EL(24)A36
Source: MHRA Published on 2024-08-12
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Class 3 Medicines Recall: Accord-UK Ltd, Trandolapril 0.5mg, 2mg, 4mg Capsules, EL(24)A/35
Source: MHRA Published on 2024-08-08
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Class 4 Medicines Defect Information: Sandoz Limited, Omeprazole products, EL(24)A/34
Source: MHRA Published on 2024-08-07
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
-
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
-
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
-
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
-
Public Workshop: Best Practices for Meeting Management Under PDUFA VII - 07/22/2024
Source: FDA Published on 2024-06-21
-
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