Tags
WDSC upcoming
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Need for maximum residue limit (MRL) evaluation for biological substances - Scientific guideline
Source: EMA Published on 2024-05-08
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CVMP recommendations on limited market classification and eligibility for authorisation under Article 23
Source: EMA Published on 2024-05-08
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Timetable: Post-authorisation safety study (PASS) protocols and final results
Source: EMA Published on 2024-05-08
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Timetable: Initial (Full) marketing authorisation application - ATMP
Source: EMA Published on 2024-05-08
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Organisation chart: Advisory functions
Source: EMA Published on 2024-05-07
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024
Source: EMA Published on 2024-05-07
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EMA closed 9-10 May
Source: EMA Published on 2024-05-07
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Information session on Call for Proposals "EU 4 AMA: leveraging European expertise for medicines regulation in Africa", Online, European Medicines Agency, Amsterdam, the Netherlands, from 22 May 2024, 10:00 (CEST) to 22 May 2024, 11:00 (CEST)
Source: EMA Published on 2024-05-07
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PRIME: priority medicines
Source: EMA Published on 2024-05-07
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List of medicines currently in PRIME scheme
Source: EMA Published on 2024-05-07
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Human medicines European public assessment report (EPAR): Emblaveo, aztreonam,avibactam, Date of authorisation: 22/04/2024, Status: Authorised
Source: EMA Published on 2024-05-07
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One Health: a joint framework for action published by five EU agencies
Source: EMA Published on 2024-05-07
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Product Management Service (PMS) Info-Day, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 16 April 2024, 09:15 (CEST) to 16 April 2024, 17:30 (CEST)
Source: EMA Published on 2024-05-07
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COVID-19 vaccines: key facts
Source: EMA Published on 2024-05-07
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Record of data processing activity relating to Security Access Control System (public)
Source: EMA Published on 2024-05-06
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FDA Roundup: May 10, 2024
Source: FDA Published on 2024-05-10
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Drug Trials Snapshots: OGSIVEO
Source: FDA Published on 2024-05-10
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Impact Story: Helping to Better Communicate the Risks and Benefits in Prescription Drug Advertising
Source: FDA Published on 2024-05-10
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Withdrawn | Expired Guidances
Source: FDA Published on 2024-05-09
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Drug Trials Snapshots: RYSTIGGO
Source: FDA Published on 2024-05-09
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OSIS Workshop: CDER Bioavailability/Bioequivalence Study Sites and Inspections of Good Laboratory Practice - 06/13/2024
Source: FDA Published on 2024-05-09
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Should You Put Sunscreen on Infants? Not Usually
Source: FDA Published on 2024-05-09
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Tips to Stay Safe in the Sun: From Sunscreen to Sunglasses
Source: FDA Published on 2024-05-09
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Expanded Access (Compassionate Use) Submission Data Archive: CDRH
Source: FDA Published on 2024-05-09
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Switching Between Biosimilars and Their Reference Counterparts with Dr. Sarah Yim
Source: FDA Published on 2024-05-08
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Drug Trials Snapshots: ZELSUVMI
Source: FDA Published on 2024-05-08
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Expanded Access (Compassionate Use) Submission Data Archive: CDER and CBER
Source: FDA Published on 2024-05-08
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OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration - 06/18/2024
Source: FDA Published on 2024-05-08
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Online Verification of Electronic Certificates of Pharmaceutical Product
Source: FDA Published on 2024-05-08
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Novel Drug Approvals for 2024
Source: FDA Published on 2024-05-08
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Field Safety Notices: 29 April to 3 May 2024
Source: MHRA Published on 2024-05-10
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Field Safety Notices: 22 to 26 April 2024
Source: MHRA Published on 2024-05-01
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Field Safety Notices: 15 to 19 April 2024
Source: MHRA Published on 2024-04-25
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Class 3 Medicines Recall: Neon Healthcare Ltd, Suprefact 1 mg/ml solution for injection (Cheplapharm – Canadian Livery), EL(24)A/14
Source: MHRA Published on 2024-04-23
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Symbios ORIGIN® Posterior Stabilised Patient-Matched Total Knee Replacement Device: Risk of Early Revision, DSI/2024/005
Source: MHRA Published on 2024-04-23
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Class 3 Medicines Recall: A. Menarini Farmaceutica Internazionale Srl, Invokana 300mg tablets (Northern Ireland only), EL(24)A/13
Source: MHRA Published on 2024-04-16
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Field Safety Notices: 8 to 12 April 2024
Source: MHRA Published on 2024-04-15
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Field Safety Notices: 2 to 6 October 2023
Source: MHRA Published on 2024-04-12
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Class 3 Medicines Recall: Accord-UK Ltd, Co-Codamol 8/500mg Effervescent Tablets (Key Pharmaceuticals Livery), EL (24)A/12
Source: MHRA Published on 2024-04-10
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Field Safety Notices: 1 to 5 April 2024
Source: MHRA Published on 2024-04-09
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0.9% Sodium Chloride Solutions for Irrigation, Inhalation, and Eyewash: recall from manufacturer Legency Remedies, DSI/2024/004
Source: MHRA Published on 2024-04-04
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National Patient Safety Alert: Reducing risks for transfusion-associated circulatory overload (NatPSA/2024/004/MHRA)
Source: MHRA Published on 2024-04-04
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Class 3 Medicines Recall: Bristol-Myers Squibb Pharmaceuticals Limited, OPDIVO 10 mg/mL concentrate for solution for infusion (nivolumab), EL(24)A/11
Source: MHRA Published on 2024-04-04
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Field Safety Notices: 25 to 29 March 2024
Source: MHRA Published on 2024-04-03
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Field Safety Notices: 18 to 22 March 2024
Source: MHRA Published on 2024-03-27
FDA
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FDA Roundup: May 10, 2024
Source: FDA Published on 2024-05-10
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Drug Trials Snapshots: OGSIVEO
Source: FDA Published on 2024-05-10
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Impact Story: Helping to Better Communicate the Risks and Benefits in Prescription Drug Advertising
Source: FDA Published on 2024-05-10
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Withdrawn | Expired Guidances
Source: FDA Published on 2024-05-09
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Drug Trials Snapshots: RYSTIGGO
Source: FDA Published on 2024-05-09
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OSIS Workshop: CDER Bioavailability/Bioequivalence Study Sites and Inspections of Good Laboratory Practice - 06/13/2024
Source: FDA Published on 2024-05-09
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Should You Put Sunscreen on Infants? Not Usually
Source: FDA Published on 2024-05-09
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Tips to Stay Safe in the Sun: From Sunscreen to Sunglasses
Source: FDA Published on 2024-05-09
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Expanded Access (Compassionate Use) Submission Data Archive: CDRH
Source: FDA Published on 2024-05-09
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Switching Between Biosimilars and Their Reference Counterparts with Dr. Sarah Yim
Source: FDA Published on 2024-05-08
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Drug Trials Snapshots: ZELSUVMI
Source: FDA Published on 2024-05-08
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Expanded Access (Compassionate Use) Submission Data Archive: CDER and CBER
Source: FDA Published on 2024-05-08
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OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration - 06/18/2024
Source: FDA Published on 2024-05-08
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Online Verification of Electronic Certificates of Pharmaceutical Product
Source: FDA Published on 2024-05-08
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Novel Drug Approvals for 2024
Source: FDA Published on 2024-05-08