iSpeak Blog

Navigating the Latest US FDA Draft Guidelines on Use of Decentralized Clinical Trial Designs

13 August 2024

The landscape of clinical trials has evolved significantly with the pandemic and interest in utilization of decentralized clinical trial (DCT) designs as a mitigation and the need for remote data collection. In response to this shift, the US Food and Drug Administration (US FDA) has released

Online Exclusives

2024 ISPE Aseptic Regulatory Panel Q&A

8 August 2024

On 13 March 2024, ISPE concluded the 2024 Aseptic Conference with a regulatory panel question and answer session. Attendees were invited to submit questions to representatives from the Austrian Agency for Health and Food Safety (AGES), US Food and Drug Administration (FDA), Regierungspraesidium Tübingen (RP Tübingen), World Health Organization (WHO), Therapeutic Goods Administration (TGA), and...

iSpeak Blog

The Pharmaceutical Industry’s Mission to Advance the Next Generation of Medicines in Collaboration with Regulators

8 August 2024

The ongoing evolution of the pharmaceutical industry, aimed at propelling the next generation of medicines requires the close collaboration with regulators, emphasizing innovation, partnership, and a continued dedication to addressing patient needs. This transformation holds the potential to guide significant advancements in the development and delivery of medicines, leading to improved...