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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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Human medicines European public assessment report (EPAR): Fymskina, ustekinumab, Status: Opinion
Source: EMA Published on 2024-07-26
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Human medicines European public assessment report (EPAR): Xadago, safinamide, Date of authorisation: 23/02/2015, Revision: 14, Status: Authorised
Source: EMA Published on 2024-07-26
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Summary of opinion: Rybrevant, 25/07/2024 Positive
Source: EMA Published on 2024-07-26
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2024
Source: EMA Published on 2024-07-26
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Human medicines European public assessment report (EPAR): Leqembi, Lecanemab, Status: Opinion
Source: EMA Published on 2024-07-26
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Human medicines European public assessment report (EPAR): Anzupgo, Delgocitinib, Status: Opinion
Source: EMA Published on 2024-07-26
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Summary of opinion: Opsumit, 25/07/2024 Positive
Source: EMA Published on 2024-07-26
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Summary of opinion: Padcev, 25/07/2024 Positive
Source: EMA Published on 2024-07-26
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EMA advises about risks of using weight loss medicine Mysimba with opioids
Source: EMA Published on 2024-07-26
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Summary of opinion: Keytruda, 25/07/2025 Positive
Source: EMA Published on 2024-07-26
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Summary of opinion: Arexvy, 25/07/2024 Positive
Source: EMA Published on 2024-07-26
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Human medicines European public assessment report (EPAR): Tuznue, trastuzumab, Status: Opinion
Source: EMA Published on 2024-07-26
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Summary of opinion: Tecentriq, 25/07/2024 Positive
Source: EMA Published on 2024-07-26
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Human medicines European public assessment report (EPAR): Ranibizumab Midas, ranibizumab, Status: Opinion
Source: EMA Published on 2024-07-26
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Summary of opinion: Spevigo, 25/07/2024 Positive
Source: EMA Published on 2024-07-26
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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 4 Medicines Defect Information: Aspen Pharma Trading Limited, Co-trimoxazole 80mg/400mg per 5ml adult suspension, EL (24)A/32
Source: MHRA Published on 2024-07-25
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Class 4 Medicines Defect Information: Fresenius Kabi Limited, Hartmann's Solution for Injection BP as Steriflex No. 11 or freeflex, EL(24)A/31
Source: MHRA Published on 2024-07-24
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Field Safety Notices: 15 to 19 July 2024
Source: MHRA Published on 2024-07-23
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Class 2 Medicines Recall: Glaxo Wellcome UK Limited (trading as GlaxoSmithKline UK), Flolan 1.5 mg Powder and Solvent for Solution for Infusion, EL(24)A/30
Source: MHRA Published on 2024-07-22
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Field Safety Notices: 8 to 12 July 2024
Source: MHRA Published on 2024-07-18
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Class 2 Medicines Recall: Sun Pharma UK Limited, Pemetrexed 1000MG/100ML (10mg/ml) & 1100MG/100ML (11mg/ml) Infusion Bag, EL(24)A/29
Source: MHRA Published on 2024-07-16
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Class 2 Medicines Recall: Sun Pharma UK Limited, Gemcitabine PPF 1800mg/180mL Infusion; Gemcitabine PPF 1600mg/160mL Infusion; Irinotecan PPF 360mg/240mL Infusion, EL(24)A/28
Source: MHRA Published on 2024-07-15
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Field Safety Notices: 1 to 5 July 2024
Source: MHRA Published on 2024-07-12
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Class 4 Medicines Defect Information: Chelonia Healthcare Limited, Propantheline Tablets 15mg (Genesis Pharmaceuticals livery), EL(24)A/27
Source: MHRA Published on 2024-07-09
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Field Safety Notices: 24 to 28 June 2024
Source: MHRA Published on 2024-07-09
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Class 2 Medicines Recall: Kent Pharma UK, Itraconazole 10mg/ml Oral Solution, EL(24)A/26
Source: MHRA Published on 2024-07-04
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Class 3 Medicines Recall: Accord Healthcare Ltd, Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg Hard Capsules, EL(24)A/25
Source: MHRA Published on 2024-07-02
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Field Safety Notices: 17 to 21 June 2024
Source: MHRA Published on 2024-06-27
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Class 4 Medicines Defect Information: PHARMATHEN S.A., Grepid 75 mg film coated tablets (Kent Pharma Livery), EL(24)A/24
Source: MHRA Published on 2024-06-24
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Field Safety Notices: 10 to 14 June 2024
Source: MHRA Published on 2024-06-21
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
-
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
-
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