Regulatory

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.

Agency leaders seek to build public trust in science and gain support for regulation.

The reporting of one man in Europe is changing accountability with compliance.

Measure tackles infant formula, cosmetics, and diagnostics—plus drug development and access.

But despite showing a tightening of focus on clinical trials and evidence, the annual report doesn’t paint the full picture.

Guidance will compel sponsors to consider new enrollment strategies and to be more diverse.

New regulations offer opportunity for simplification in strategic planning.

Tech companies entering space must adapt and adhere to regulations set by FDA.

EMA’s new release factors in scientific advances, clarity on trial designs.

Chatbots can benefit regulatory landscape in light of evolving standards and guidelines.

ICH draft guidance proposes standardized framework for identifying ways development programs for adult treatments can inform pediatric studies.

Just-released analysis by Prescrire contends that the agency “is backtracking on commitments to clinical data transparency.”

Plan to keep new methods adopted during COVID in place.