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With nitrite concentration in excipients being a key risk factor in nitrosamine drug substance related impurities (NDSRI) formation, there is opportunity to implement corrective and preventative actions (CAPAs), EMA experts say.
In this article, Aman Khera and Dr Christine Moore of Worldwide Clinical Trials share how regulatory agencies are supporting psychedelic research through expedited pathways and outline some of the key considerations for clinical trials sponsors.
The UK’s regulator approved Novartis’ radioligand therapy Pluvicto®▼ and radioactive diagnostic agent Locametz® for use in advanced prostate cancer.
MHRA approves Moderna’s adapted COVID-19 vaccine, Spikevax bivalent Original/Omicron, for use as a booster.
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on far-reaching proposals to revise the clinical trial legislation in the UK.
The roadmap clarifies the processes to develop advanced therapy medicinal products (ATMPs), providing guidance on key considerations.
Two new guidance documents, the first in a series to published by the MHRA, outline considerations when planning a randomised clinical trial using real-world data.
The FDA and other global regulators are co-operating to address inadequacies in clinical research that leave pregnant and breastfeeding women lacking data on which to base their medical decisions.
![MBE Medals [Credit: HCSA (Health Care Supply Association)].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/MBE-300x278.png)
![MBE Medals [Credit: HCSA (Health Care Supply Association)].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/MBE.png)
Professor Tom Clutton-Brock was awarded an MBE for his work in approving novel ventilators for the UK’s National Health Service during the COVID-19 pandemic.
The Janssen COVID-19 Vaccine has been granted conditional marketing authorisation for use in people aged 18 and over in the UK.
The UK’s MHRA has stated that manufacturers must instead issue a Declaration of Conformity to Directive 93/42/EEC and register their Class I medical device with an EU Competent Authority.
The European Medicines Agency (EMA) said its assessment of the conditional marketing authorisation (CMA) application will be performed under a reduced timeframe, with a decision potentially delivered in weeks.
Dr Abhishek Dadhich rounds up how the Indian pharmaceutical market has been impacted by the coronavirus pandemic and the steps the country’s government could take to overcome these setbacks.
