The European Medicines Agency (EMA) organised a hybrid SME (small and medium-sized enterprises) info day on 18 October 2024. The SME info day is a training event dedicated to small and medium-sized enterprises in the...
Since 2022, the European Medicine Agency’s (EMA) Industry Standing Group (ISG) meets four times per year to enable an exchange of views between the Agency and stakeholders in the pharmaceutical and medical device industries. The group...
The FDA has issued a draft guidance which provides recommendations for the development of drug and biological products for the treatment of patients with bacillus Calmette-Guérin (BCG)-unresponsive nonmuscle invasive bladder cancer (NMIBC) and is intended for pharmaceutical...
This guidance released in August 2024 is intended to assist sponsors in identifying an optimised dosage(s) for human prescription drugs or biological products for the treatment of oncologic diseases during clinical development and prior to submitting an...
FDA has issued a revised guidance providing recommendations to holders of approved new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs) regarding the reporting and implementation of some common changes to container...
This draft document provides guidance to industry and FDA staff on the purpose and content of a use-related risk analysis (URRA) and how a URRA, along with other information, can be used to determine human factors (HF)...
Committee Science and Technology Committee (Lords), Inquiry Engineering biology The session will focus on engineering biology developments within the commercial sector; the challenges faced by companies wanting to scale up within the UK; and which areas within...
Committee Science and Technology Committee (Lords), Inquiry University Spin-out Companies The session will focus on the independent review of university spin-out companies; the challenges faced by companies wanting to scale up; and what the Government could do...
Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance Draft Guidance for Industry and Food and Drug Administration Staff End date: 23rd April 2024 Draft Guidance Published on the 5th...
Use of Data Monitoring Committees in Clinical Trials Guidance for Industry End date: 16th April 2024 Draft Guidance Published on the 5th of March 2024 in Catapult’s regulatory round-up for february 2024.
