Regulatory

Despite agreement on recommendations between European regulators, DCT unclarity remains.

The Consolidated Appropriations Act for 2023 includes dozens of measures involving drug development and regulation.

Michelle Webb, vice president of the WCG Avoca Quality Consortium, discusses her perspectives on FDA's revised overview of inspection activities.

Insights from second annual DTRA meeting indicate DCTs are here to stay.

Automating process can reduce time and resources lost from using manual steps and allows stakeholders to maintain compliance.

A roadmap to avoiding the common pitfalls of concurrent FDA-EMA filings.

Summarizing important FDA and EMA revisions issued this year.

Navigating FDA’s draft guidance and heightened diversity recommendations.

Debates caught between focusing on existing antibiotics and developing new agents.

Looking back on major FDA moves in 2022.

Marci Macpherson, executive director, quality assurance and compliance at Ionis Pharmaceuticals, discusses her perspectives on inspection readiness.

Inaugural group of members added to EMA’s new data network focused on RWE.

New guidance to drill down on more specifics in hopes of harnessing the growth of these types of studies.

Following closely contested election, approval of FDA bills most likely tabled until new year.

Rare disease stakeholders speak out ahead of anticipated EU changes.

Virtual audits proving to be beneficial post-COVID despite continuing challenges.

Potential drug removal spotlights latest debate over the expedited pathway.

Smoothing path to CTIS compliance will be key in overall effort to transform clinical trials in Europe.

New EU clinical trial regulation places heavy importance on patient-submitted documents.

Sheri Kuss, clinical quality group lead at Pfizer, discusses the new "culture of quality" in clinical trials.

The hope is to build a formal framework for using digital health technology in clinical trials in Europe and beyond.

CBER maps modernization plan to handle surge in research and applications.

The ‘skinny’ user fee reauthorization tables multiple high-profile proposals.

Agency releases a series of new guidances to advance the reliability of patient-focused tools and methods.

Seek pared-down measure in funding bill to avert shutdown.