Regulatory

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.

Agency officials express associated concerns around clinical trial data reliability and quality.

Administration launches national manufacturing initiative, with aim to reduce US reliance on biomedicine from China and other regions.

Proposed US merger could threaten innovation in cancer diagnosis, Commission officials assert.

In countdown to renewal deadline, agency already feeling the effects of still-unclear legislative fate.

Commission pushes for a “more unified” approach to drug development following a period of fragmented coordination during the pandemic.

Orientation pursuits hit high gear as formal rule compliance inches closer.

Identifying and providing clarity on the GCP quality and risk concerns associated with DCT modalities.

Pharma loses battle to block price negotiations, but implementation faces many challenges.

Newly unveiled workplan focuses on harnessing the impact of big data on drug development—and ultimately public health.

Better clinical data needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety.

Recent updates from regulatory bodies are providing more confidence in integrating different forms of trials and technology.

Citing strong reporting results, hybrid model to continue supplementing on-site inspections.

The scope of RWE’s use in developing and approving new medicines is pitting key healthcare stakeholders against each other.

With debate swirling around products cleared through this pathway, reforms and tighter oversight likely.