Modern Tools to Advance Generic Drug Development and Review
Generic prescription drugs that are approved by the FDA have the same high quality and strength as brand-name drugs. Likewise,…
Generic prescription drugs that are approved by the FDA have the same high quality and strength as brand-name drugs. Likewise,…
Many rare diseases are “monogenic” – that is, they are the consequence of a defect in a single gene. Daniel…
Whether enabling new approaches to patient safety monitoring and clinical trials, or improving success rates for regulatory submissions, artificial intelligence…
The US Food and Drug Administration (FDA) frequently stress the importance of enrolling diverse patient populations in clinical trials conducted…
Robust intellectual property protection is essential to safeguarding the future of revolutionary biomedical innovations, which transform healthcare for millions of…
As part of its Clinical Trial Transparency initiative, the EMA mandated a requirement for clinical trial sponsors to prepare a…
Rossen Mihaylov at Ramus Medical discusses the challenges faced during the preparation and conduct of clinical investigations. For both medical…
The major objective of pharmaceutical research & development is to bring new health solutions to people who need them. Lionel…
Clinical trials are becoming increasingly complex, particularly with broader scopes, globalisation, changing and expanding regulatory requirements and a greater number…
The first-in-human trial (FIH) is an important milestone in the development of a potential new drug. Nariné Baririan at SGS…