January 22, 2018

Government Shutdown Temporarily Ends or Delays Some FDA Work

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.

The Pulse on Study Conduct

Educate yourself on new therapeutic areas

Medical knowledge for the vast assimi­lation of clinical research guidelines is necessary for anyone entering the field. The diverse regulatory landscape requires us to stay abreast of changes that impact patient safety data. It is a multifaceted learning process with educational requirements that vary by role. We should never expect anyone to have every answer, or to know everything about a protocol/therapeutic area. That sets an unreal­istic standard that undermines performance.