Regulatory

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.

Leaked draft gives glimpse into potential new research proposals as part of the EU’s Horizon program.

The US Congress approved a federal spending package that increases funding for a range of programs to advance health and medicine.

Organization says either reform European drug development rules—or lose out on global competition.

Continued embrace of precision dosing will reduce costs and optimize clinical outcomes.

New proposals aim to create higher standards for trial regulation.

A review of submission formats for drug development.

New EU guidance now officially in effect.

High upfront patient costs limit access to low-income populations.

In a highly unusual decision for a therapy approved by FDA, CMS has taken action to limit prescribing and use of Biogen’s new and controversial Alzheimer’s treatment Aduhelm.

Investigational medicinal products, trial sponsors, and registration all impacted by UK exit.

Survey uncovers pediatric-patient perspectives on plain language summaries.

Roadmap of twists and turns that lie ahead following most recent draft issued in September.

Lessons learned from FDA’s current process and proposed alternative review strategies.

Increased public engagement leads recent change in EMA profile.

Lessons learned from COVID-19 vaccine development.

Improving receptivity and response to the evolving nature of clinical trial patient oversight.

Implementing new strategies with the use of patient-reported outcomes.

Higher costs headline list of new challenges faced by CROs and sponsors.

The data, not the plan, provide the direction.

Developing new pathways to overcome study-related challenges is key to realizing the promise of the latest gene therapies.

FDA emphasizes importance of inclusion in trials.

President unveils lengthy program for combatting COVID-19 immediately following inauguration.

Cancer still a primary focus of EMA in light of COVID and vaccine development.

Implementing disclosure and data transparency policies and procedures represents an opportunity for sponsors, rather than an obligation.

Researchers aren't taking full advantage of advances in trial technologies. A lack of clarity in the current version of the International Council for Harmonization "Guidelines for Good Clinical Practice", could be the problem.

Recent webcast addresses what organizations can do to prepare for the next revision of ICH E6.

Looking back on regulatory challenges created by COVID in 2020.