The European Medicines Agency has developed draft recommendations on the key methodological factors to consider when conducting and assessing observational studies with real-world data for regulatory decision-making throughout a medicine's lifecycle.

Drawing references from the EU and US guidelines for decentralized clinical trials, the Egyptian FDA has framed draft requirements that sponsors should consider when planning to use off-site nurses in their drug and medical device studies.

Drawing references from the EU and US guidelines for decentralized clinical trials, the Egyptian FDA has framed draft requirements that sponsors should consider when planning to use off-site nurses in their drug and medical device studies.

The Netherlands’ Central Committee on Research Involving Human Subjects is gauging sponsor demand for a new scientific advice service for clinical trials, which is for now free of charge.

The Netherlands’ Central Committee on Research Involving Human Subjects is gauging sponsor demand for a new scientific advice service for clinical trials which is for now free of charge.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.