Clinical Trials Advisor

Due to summer holidays, Clinical Trials Advisor will not be published July 5. The next issue will be published July 19.

The FDA should work with other regulatory bodies, especially the European Medicines Agency (EMA), to create a single marketing application that would be accepted by multiple regulators, drug industry insiders urge.

The FDA is moving toward requiring premarket approval applications (PMAs) for diagnostics that are paired with specific drugs, rather than the less stringent 510(k) or de novo 510(k) pathways that are most often used now, said Christine Gathers, senior director of regulatory affairs for Eli Lilly.

A dishonest and insubordinate study coordinator has compromised a clinical trial, endangered subjects and led the site’s clinical investigator to discontinue conducting clinical research, according to an FDA warning letter.

To smoothly transition clinical investigation oversight from one IRB to another, new and old IRBs, clinical investigators, sponsors and CROs should work closely to minimize disruptions to the ongoing trial and ensure subjects are constantly protected, according to a new draft guidance.

CINCINNATI — Regulatory advances made during the Innovation Pathway 2.0 project to develop new treatments for end-stage renal disease may quickly be rolled throughout the Center for Devices and Radiological Health (CDRH), center Director Jeffrey Shuren said at the recent FDA/Xavier University MedCon Conference.

Device and drugmakers need to engage patients earlier in the development process to ensure they are addressing symptoms and measuring outcomes that matter to patients, patient advocates say.

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) is seeking public input as it works to update its points-to-consider document on multiplicity issues in clinical trials.

The FDA has revised its guidance on testing a new drug’s genotoxicity to help drugmakers optimize the standard genetic toxicology battery and better predict potential human risks.

Devising strategies to engage physicians, teaching hospitals and medical societies will be critical to implementing a successful Sunshine Act compliance program, healthcare compliance expert Michaeline Daboul says.

Experts are wondering whether Johnson & Johnson (J&J) made the right decision when it unblinded its pivotal trial for a supplemental indication for prostate cancer treatment Zytiga before the study met its overall survival endpoint.

The FDA has outlined provisional trial designs, study endpoints and efficacy analyses that can be used for testing and assessing new irritable bowel syndrome (IBS) drugs until a well-defined and reliable patient-reported outcome (PRO) tool — the ideal efficacy assessment instrument — can be developed.