Clinical Trials Advisor

The FDA has updated its draft guidance on best practices for conducting safety studies using electronic healthcare data sets after receiving more than 400 comments on its recommendations.

The FDA recently informed a group of gastroenterological specialists that fecal microbiota transplantation (FMT), also known as a stool transplant, should be considered a biological product under agency oversight when treating Clostridium difficile (C. difficile) infection.

Eli Lilly has put the brakes on a Phase III trial of its non-Hodgkin’s lymphoma (NHL) drug enzastaurin after it failed to meet its primary endpoint.

When shopping for an IRB, sponsors should pay particular attention to whether the review board offers a single point of contact and whether that contact is qualified to handle the sponsor’s needs.

The European Medicines Agency has joined the FDA in adopting draft international guidelines on identifying and mitigating impurities in drugs that use genotoxic or carcinogenic starting materials.

Investigators contemplating their own clinical trials need to understand the regulatory framework of investigator-initiated studies and what it means to be a sponsor investigator before wading into the water, a legal expert says.

Companies that want to charge patients for an investigational drug during a clinical trial must prove to the FDA that the trial could not otherwise be conducted “because the cost of the drug is extraordinary,” according to a draft guidance.

To improve engagement between the European Medicines Agency (EMA), drugmakers and scientific committees, the agency is putting in motion planned changes discussed late last year.

The FDA’s draft plan for implementing standard benefit-risk templates in drug reviews lacks a process for including patient concerns, the National Organization of Rare Diseases (NORD) says.

GOP House leaders are investigating the brief tenure of Leona Brenner-Gati in the wake of the former FDA acting deputy commissioner’s sudden departure earlier in May.

As part of fulfilling a key user fee commitment, the FDA is asking the White House to approve plans to survey companies that submit applications to the agency to assess the effectiveness of a new drug approvals transparency initiative.

The European Medicines Agency May 8 published recommendations for drugmakers on the use of phthalates and parabens, urging consideration of patient populations.

The FDA has released a new manual for its Office of Pharmaceutical Science Coordinating Committee (OPS CC), updating the committee’s organizational structure, procedures and responsibilities.