Regulatory

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ICH draft guidance proposes standardized framework for identifying ways development programs for adult treatments can inform pediatric studies.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

EMA continues to familiarize industry with new clinical trial legislation.

‘Independence’ the priority for the longstanding European Organization for Research and Treatment of Cancer, Winette van der Graaf tells Applied Clinical Trials in interview.

Medical device user-fees agreement, Aduhelm approval and access among issues in crosshairs.

Oncology drug developers must start asking questions in preparation of FDA’s dose optimization initiative.

Stress the importance of clinical studies today—and urge for formal approach to managing the pandemic and addressing specific public health needs more sustainably.

Dual efforts focused on more inclusive research and more diverse enrollment in pre- and post-approval studies.

Transition likely with looming end to emergency use authorizations tied to COVID-19 pandemic.

Remote inspection and ICH guidelines among topics discussed at Veeva's most recent TMF Innovation Forum.

Program looks to establish framework for agency and purchasers to “objectively rate” manufacturing sites.

Alleviating sponsor and investigator concerns around sharing of remote-assessment data in accordance with GCP and GDPR standards.

Study evaluates the use of AI-supported medical coding module.