Regulatory

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.

With the renewal deadline looming—and disagreement still swirling on enhancing FDA authority—a counter proposal calls for a streamlined, fee-only bill.

Payers join the push for better demonstrations of efficacy of new medicines.

Why oncology needs dosing redesign.

Largely discarded topic beginning to grab hold in policy discussions.

All stakeholders must play part in increasing implementation.

Amid push to include this population more in clinical trials, the goal is to uncover improved evidence on the risks/benefits of drugs for these patients.

Battle lines being drawn among key healthcare constituencies, as discussions around new approaches to drug evaluation and decision-making heat up.