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News Archive
EMA - CVMP Meeting Highlights 18-20 April 2023
26th April 2023Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 18-20 April 2023
EMA - CTIS newsflash – 21 April 2023
26th April 2023This regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.
EMA - Clinical Trials Highlights 14
26th April 2023April 2023 issue of Clinical Trials Highlights.
EMA - Human Medicines Highlights Newsletter 168
26th April 2023Key information for patients, consumers and healthcare professionals.
EMA - PRAC 11-14 April 2023
26th April 2023Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 April 2023
EMA - Reducing risks to human and animal health from exposure to N-methyl pyrrolidone in veterinary medicines
26th April 2023On 8 December 2022, EMA’s veterinary medicines committee, the CVMP, recommended new measures to reduce the risks from exposure to the excipient N-methyl pyrrolidone (NMP) for women who may handle NMP-containing veterinary medicines and animals that are given these medicines.
EMA - Single-arm trials as pivotal evidence for the authorisation of medicines in the EU
26th April 2023EMA has opened a public consultation on a PDF icon reflection paper that discusses key concepts for single-arm clinical trials that are submitted as pivotal evidence in support of marketing authorisation applications for medicines in the European Union (EU).
FDA - A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers
26th April 2023This guidance provides information on risk-based approaches to monitoring the conduct of clinical investigations of human drug and biological products, medical devices, and combination products.
FDA - Final Guidance on Animal Drug User Fees and Fee Waivers and Reductions
26th April 2023This version of the guidance replaces the version made available in July 2017. This revision of the guidance document updates hyperlinks, mailing, and contact information.
FDA - The Office of New Drugs' Efforts to Expand Regulatory Science Research
26th April 2023CDER’s Office of New Drugs (OND) developed a research program in 2018 to centralise and enhance its regulatory science research activities. Recently, the OND Research Program (OND-RP) published its first two fiscal year annual reports
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