Clinical Trials Advisor

An FDA advisory panel March 29 voted 17–6 to recommend requiring drugmakers to rule out cardiac risks of investigational obesity drugs, even if a theoretical risk or signal for harm is not present.

The Senate has released its draft of a bill on accelerated approval changes, largely mirroring Sen. Kay Hagan’s (D-N.C.) TREAT Act and giving a strong indication of what could come in a final FDA user fee bill.

Clinical sites are on better financial ground than in past years, according to a new survey, but the landscape is still unstable — meaning research clinics must get more savvy to survive.

Two programs intended to encourage pediatric trials of critical-need drugs could be made permanent under a new House bill.

To take full advantage of alliances or strategic partnerships with CROs, pharmaceutical and biotech companies must look at contractors as more than just vehicles for cost reduction, and instead transform their work flow and culture to best benefit from these relationships, a new report concludes.

Sponsors, CROs and clinical investigators should have an easier time determining what drug development data in an EU marketing authorization is destined for public consumption, thanks to a new European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) joint guidance.

Drug industry stakeholders using the FDA’s Bioresearch Monitoring Information System (BMIS) to analyze clinical research trends may not have been getting as accurate a picture as they thought.

The FDA will consider adding a mandatory pre-522 discussion period before issuing postmarket surveillance orders, officials at a March public workshop on the process said.

Determining whether your clinical study needs to be registered on ClinicalTrials.gov is not always as clear cut as it may seem, and the task only becomes trickier once a product is approved and study results must be made public.

The senators who co-authored the Physician Payments Sunshine Act are trying once more to exercise their legislative oversight — this time setting a June deadline for overdue implementation of the rules.