Clinical Trials with Genetically Modified Organisms (EU)
Investigational medicinal products (IMPs) that contain or consist of genetically modified organisms (GMOs) constitute a special regulatory case.
Regulation of medical and in vitro diagnostic medical devices in the UK (Great Britain and Northern Ireland)
In the European Union (EU), medical and in vitro diagnostic medical devices are regulated by an EU framework that aims to ensure that all devices available for use on the EU market are safe and perform as intended
Scientific advice (US-FDA)
The FDA has four meeting types, type A (help a stalled product development program), type B (pre-IND meeting, pre- NDA/BLA meeting, meeting to discuss overall development for products granted breakthrough therapy designation), end of phase type B (certain end of phase 1 meetings, end of phase 2 and pre phase 3 meetings), and type C (any meeting regarding development and review of a product that isn’t any of the other types).
Preparing for the Clinical Trials Regulation (CTR)
The CTR (Regulation (EU) No 536/2014) replaces the EU Clinical Trials Directive and local implementing legislation and provides the requirements for conducting clinical trials in member states of the European Union (EU).
The Clinical Trials Regulation and the Clinical Trials Information System
The way clinical trials (CTs) are conducted in the European Union (EU) will undergo a major change when the Clinical Trials Regulation (CTR) (Regulation (EU) No 536/2014) comes into application on 31 January 2022. The CTR replaces and expands the scope of the existing EU CT Directive (CTD) 2001/20/EC. The CTR will also apply to all CTs previously authorised under the CTD if still ongoing after 31 January 2025 (see also transition period). The CTR does not apply to non-interventional studies.
Orphan Drug Designation (US)
The FDA has the authority to grant orphan drug designation to a drug or biological product to prevent, diagnose or treat a rare disease. Download our 2-page Orphan Drug Designation (US) factsheet for more information.
