Features

FDA to Begin Publishing Clinical Study Reports & Possibly Select CRLs

January 22, 2018

A new FDA pilot program will publish information from sponsor-produced clinical study reports (CSR) — starting with documents volunteered by companies following a drug’s approval — as part of broader agency efforts to boost transparency in clinical trials and streamline the review process.

Government Shutdown Temporarily Ends or Delays Some FDA Work

January 22, 2018

Congress’s failure to pass a government spending bill last weekend means much — but not all — of the FDA’s work will stop until the government is funded. Firms should be aware that scheduled meetings with FDA will more than likely need to be postponed and rescheduled, said Steven Grossman, deputy executive director of Alliance for a Stronger FDA. “Certainly, medical product companies with near-term expectations — review meetings, initiating clinical trials, etc. — are faced with the possibility of slippage in their development timelines,” he said.

Tufts Study: New Data Slows Trials Down

January 15, 2018

While the burgeoning amount of data collected in clinical trials promises to add more depth and breadth to study endpoints, leading to better studies and better drug therapies, for now it’s doing more harm than good by increasing data management burdens.

Common Rule Confusion Clouds Industry Preparedness

January 15, 2018

As the January 19 implementation date of the revised Common Rule approaches, the question remains as to whether or not implementation of the revised rule will be delayed — leaving many feeling uncertain.

FDA & CTTI Launch Patient Forum to Boost Engagement in Drug Development

January 8, 2018

The Patient Engagement Collabora­tive is gearing up for a launch in early 2018. The new, external panel is being built by the FDA and the Clinical Trials Trans­formation Initiative (CTTI), a public-private partnership between the FDA and Duke University. The panel will act as a forum for discussing new methods to increase patient participation in the agency’s decisionmak­ing process. It will provide input on incor­porating patient-preferences into reviews of medical products and trial protocols to make patient engagement an integral part of drug development.