Generic prescription drugs that are approved by the FDA have the same high quality and strength as brand-name drugs. Likewise, the manufacturing and packaging sites …

Many rare diseases are “monogenic” – that is, they are the consequence of a defect in a single gene. Daniel Mazzolenis and Jozsef Palatka at …

Whether enabling new approaches to patient safety monitoring and clinical trials, or improving success rates for regulatory submissions, artificial intelligence (AI) offers enormous potential to …

The US Food and Drug Administration (FDA) frequently stress the importance of enrolling diverse patient populations in clinical trials conducted to support product applications. Meg …

Robust intellectual property protection is essential to safeguarding the future of revolutionary biomedical innovations, which transform healthcare for millions of people worldwide. Jim Robertson and …

As part of its Clinical Trial Transparency initiative, the EMA mandated a requirement for clinical trial sponsors to prepare a summary of the results of …

Rossen Mihaylov at Ramus Medical discusses the challenges faced during the preparation and conduct of clinical investigations. For both medical drugs and devices, CROs face …

The major objective of pharmaceutical research & development is to bring new health solutions to people who need them. Lionel Bascles and Victoria (Vicky) DiBiaso …

Clinical trials are becoming increasingly complex, particularly with broader scopes, globalisation, changing and expanding regulatory requirements and a greater number of players, such as contract …

The first-in-human trial (FIH) is an important milestone in the development of a potential new drug. Nariné Baririan at SGS discusses how going ahead with …