Blogs

ICH draft guideline advocating a more comprehensive framework in optimizing pediatric drug development reaches next step.

Several legislative initiatives on table that would extend agency’s reach

What to make of UK’s draft resolution set for review on the international stage.

IP claims under microscope amid arguments over R&D policy and investment.

Industry must work closely with patients to advance the use of decentralized technology.

Agency report reveals solid results from the first five years of its PRIME scheme, but also calls for improvements in focus.

From supply-chain and clinical-trial disruptions in Ukraine and Russia, to decisions to halt investment or maintain operations, global implications for industry and pharmaceutical production are immense.

Industry benefits from heightened innovation, site/sponsor relationships, and diversity.

Clinical data strategy and analytics, wearables and digital biomarkers, and risk-based quality management highlight notable takeaways.

In this article and video, Applied Clinical Trials blogger and Head of Research for CliniBiz Moe Alsumidaie, MBA, MSF, takes a deep dive into the reasons behind the CRA shortage and how industry can proactively address this problems.

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EU’s new health innovation center unveils several projects focused on advancing R&D, medical countermeasures, and related technologies.

Agency clarifies stance on applications for ‘me-too’ drugs not supported by multiregional trials.

Pressurized political, COVID climates greet his return to top spot.

2022 EU initiative provides hope for improvement of trial regulations.

EMA officially launches coordination center to systemize data analysis and real-world interrogation.

Agency restarts more routine site visits amid slowdown of new COVID infections.

Political issues delay Senate confirmation of Califf.

New EU guidance now officially in effect.

New package to clarify responsibilities for federal health agencies.

Uncertainty over experimental medicines calls for review of AA process.

International collaboration needed to address distribution hurdles.

New guidance looks to streamline safety assessment process.

Dr. Harish Dave, CEO of Singapore-based AUM Biosciences, discusses evolving strategies for Asian biopharmaceutical enterprises.

New therapies were approved at a steady pace in 2021.

The European Union is reaching out for independent experts to help advise on its health development programs in needy areas of regulatory science.

The Innovative Health Initiative is expected to launch its first call for proposals early this year.

Pfizer’s Paxlovid has gained emergency use authorization at a time when the U.S. is being devastated by the spreading Omicron variant.

Object lessons in implementing next-generation sequencing in cancer diagnosis in Europe.

Pressure grows for advances in drug development.