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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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Cyanokit
Source: EMA Published on 2024-12-19
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Veterinary medicines European public assessment report (EPAR): Nobivac L4, Vaccine to prevent Leptospira infections in dogs, Status: Authorised
Source: EMA Published on 2024-12-19
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Veterinary medicines European public assessment report (EPAR): Versican Plus DHPPi, canine distemper virus, canine adenovirus, canine parvovirus, canine parainfluenza virus, Status: Authorised
Source: EMA Published on 2024-12-19
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Veterinary medicines European public assessment report (EPAR): Versican Plus DHPPi/L4, live, attenuated Canine distemper virus, canine adenovirus, canine parvovirus, canine parainfluenza virus inactivated, Status: Authorised
Source: EMA Published on 2024-12-19
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Trametinib product-specific bioequivalence guideline
Source: EMA Published on 2024-12-19
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Veterinary medicines European public assessment report (EPAR): Purevax RCP FeLV, Vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline leukaemia, Status: Authorised
Source: EMA Published on 2024-12-19
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Veterinary medicines European public assessment report (EPAR): Purevax RCP, vaccine against feline viral rhinotracheitis, feline calicivirosis and feline panleucopenia, Status: Authorised
Source: EMA Published on 2024-12-19
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Veterinary medicines European public assessment report (EPAR): Purevax FeLV, vaccine against feline leukaemia, Status: Authorised
Source: EMA Published on 2024-12-19
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Article 57 product data
Source: EMA Published on 2024-12-19
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Alofisel
Source: EMA Published on 2024-12-19
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Human medicines European public assessment report (EPAR): Vanflyta, quizartinib, Date of authorisation: 06/11/2023, Revision: 3, Status: Authorised
Source: EMA Published on 2024-12-18
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Human medicines European public assessment report (EPAR): Travatan, travoprost, Date of authorisation: 27/11/2001, Revision: 31, Status: Authorised
Source: EMA Published on 2024-12-18
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Standard operating procedure for processing of requests for fee reduction falling under paragraph 5 of Article 6 of Regulation (EU) 2024/568
Source: EMA Published on 2024-12-18
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Human medicines European public assessment report (EPAR): Voncento, human coagulation factor VIII / human von willebrand factor, Date of authorisation: 12/08/2013, Revision: 16, Status: Authorised
Source: EMA Published on 2024-12-18
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Human medicines European public assessment report (EPAR): Afstyla, lonoctocog alfa, Date of authorisation: 04/01/2017, Revision: 11, Status: Authorised
Source: EMA Published on 2024-12-18
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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 Notification: Argenx BV, Vyvgart 1000 mg solution for injection, EL (24)A/63
Source: MHRA Published on 2024-12-19
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Field Safety Notices: 9 to 13 December 2024
Source: MHRA Published on 2024-12-17
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Field Safety Notices: 2 to 6 December 2024
Source: MHRA Published on 2024-12-10
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Class 2 Medicines Recall: Wockhardt UK Limited, WockAIR 160 microgram/4.5 microgram, inhalation powder, EL(24)A/62
Source: MHRA Published on 2024-12-09
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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
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