Category: Biopharma

Turkish Medicines and Medical Devices Agency (TMMDA) issued guidance in order to determine the principles and procedures for the import of products to be used in clinical research studies conducted...

This new regulation offers for extra measures to limit the unavailability of medicines. On 3 February 2020, the law of 20 December 2019 amending various legislations regarding medicines shortages was...

The US Food and Drug Administration (FDA) revised its draft guidance provides information on the implementation of section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21...

The European Commission (EC) published a new site suitability template that sponsors of clinical trials can use as part of the application dossier under the EU’s new clinical trial regulation, which...

Drug development has become highly complex than ever before since the globalization of the life sciences industry. Regulatory Intelligence (RI), which emerged about 15 years ago, is comparatively a...